chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCHING; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: various allergies, chronic migraines, restless leg syndrome, hypothyroidism, asthma, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had allergy to steroids increase pressure in the eyes. Patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with tramadol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for allergic symptoms, thyroid for hypothyroidism, rimegepant sulfate for migraines, and topiramate for migraines.  On 08-DEC-2021, the patient experienced itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching. This report was non-serious.
Patient had Pfizer booster vaccine along with Tdap vaccine yesterday. Today, after walking downstairs and being in the kitchen, patient fainted
Seizure reported as full body shaking and post ictal period observed at home at 08:20 AM with fever. Admitted to hospital and diagnosed with complex febrile seizures. Full septic work up negative.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot# M027884 (also reported as: M0027884), expiration date: 19-APR-2019, (dose and route of administration were not reported) for prophylaxis. Administered doses of vaccine underwent a temperature excursion from 22 degrees Fahrenheit to 37 degrees Fahrenheit for 1381 hours in total. There was no previous temperature excursion. Data logger was not involved. There were no adverse effects reported.; Sender's Comments: US-009507513-1709USA006071: US-009507513-1709USA009874: US-009507513-1709USA009815: US-009507513-1709USA009750:
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ liquid, orally, lot# M014318, expiration date: 30-SEP-2017 (dose was not reported). The temperature excursion ranged between 32 and 36 degrees Fahrenheit and lasted 72 hours. There was no previous temperature excursion. Digital data logger was not used. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000842: US-009507513-1703USA005126: US-009507513-1703USA005127: US-009507513-1703USA005128:
Passed out without warning; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8729; Expiration date was not reported) on the left arm on 13Apr2021 (09:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the public health department. Medical history included lower back pain; allergy to latex; and allergies with bananas and avocados. The patient was not pregnant at the time of vaccination. The patient's concomitant medication included an unspecified pain medication. The patient previously took ketorolac (TORADOL), and had allergies with this medication. On 13Apr2021 (10:00), the patient had passed out without warning; assessed as serious (medically significant). The patient did not receive any treatment for the event. The outcome of the event was unknown. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.
I cannot lift up my arm for 2 weeks and when I call to the farmacy they told me to apply some ice packs and I did .  One day after the ice pack apply I have bruises under my skin and it feel like burning when I touch it.  Until today (11-23-2020) the bruises still  stay on my left arm.  I still can?t lift up my arm high.
I had zero symptoms with my first two shots (2/20/21 and 3/13/21). After getting my 3rd shot at 10:30 AM on 8/28/21 (Saturday), in the middle of the night, I woke up with a very sore left arm, extreme muscle aches all over my body, the chills, headache, nausea, and extreme fatigue.  I slept a total of 29 hours.  By Tuesday (8/31/21) I was back to normal.  I just found that I experienced all of these symptoms with the third shot after having zero with the first two.
large red splotch that itches, stings, burns, feels hot spread over night despite benadryl,
Hands and feet were tingling, anxious, requested a b/p check. Evaluated by EMS, cleared.
Patient age 73 Admit to local Medical Center 12/2/2022 initially with pneumonia. Respiratory failure secondary to COVID was noted on patient's chart. COVID positive 12/20/2022. Date of death: 1/5/2023. County: PRIVATE. Vaccinated with Pfizer x2
FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers .No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and headache on MAR-2021. This report was non-serious.
Became extremely ill after every anthrax vaccination. To this day I have skin conditions no one can explain. I found out in 2012 that I could not have children.
Within 10 minutes of administration: Flushing, feeling of collapse, vomiting, nausea, diarrhea, chest pain, immediate burning at injection site which lasted 6 hours
suspected vaccination failure; got the Shingles shot / got Shingles again; swelling at the site of injection; fever; pain/residual pain; extremely sensitive to heat in that area; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Neurontin.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site swelling, fever, pain and heat sensitivity. On an unknown date, the outcome of the vaccination failure, shingles, injection site swelling, fever, pain and heat sensitivity were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, injection site swelling, fever, pain and heat sensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received the Shingles shot and experienced shingles, swelling at the site of injection, fever and pain. At the time of reporting, the patient had residulal pain and that area was extremely sensitive to heat. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration; expired dose administered on 06-APR-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered on 06-APR-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered on 06-APR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered on 06-APR-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was stored in refrigerator on the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received first booster dose of Moderna vaccine on 06-Apr-2022.    Concomitant medication information was not provided.    The vial was initially stored in the refrigerator on 05-Apr-2022.    The healthcare provider had a lot number of the vial which they thought expired at a different time. However, when the healthcare provider entered the lot number on Moderna's online expiration tool look up, it was found that the lot had expired on 02-Apr-2022.    The healthcare provider reported that each patient was administered with the dose from a different vial and each of the vial was stored in the refrigerator on the day before administration.    The vial did not undergo any temperature excursions. It was reported that the patient had not reported of experiencing any adverse reactions to this expired dose.    Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Live Follow up received contained non significant information.
Patient received a tetanus toxoid to Right deltoid on 10/13/11 at Hospital ER for MVC. Noted to have pain & redness with skin redness about 30 hours later with generalized myalgias and arthralgias & weakness.
This literature marketed report has been received from the author of a published literature article and refers to a 4-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in Summer 2018 (reported as "last summer"), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally (dose, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient developed intussusception, an intestinal obstruction after receiving the vaccine. The consumer reported that her son's intestines fold in on itself and the patient almost died. The outcome of the event was unknown. The author considered the event to be related to the suspect vaccine. Upon internal review, the event of intussusception was considered to be medically significant and life-threatening.
May 14-16: severe muscle aches over entire body, including injection site in right arm June 2: Sharp and prolonged neck pain and burning sensation in legs, especially while driving/sitting for long periods Gradual increase in severity of symptoms. First sought treatment in August 2021. Gradual worsening of leg pain until I had difficulty walking. Muscle weakness. Sudden weight loss (8 pounds between August and September of 2021, without dieting). By early September, both knees were inflammed. Loss of function. Could not walk without stiffness. Difficulty getting in and out of bed, bathtub, using toilet. Difficulty climbing stairs, getting dressed, activities of daily living, opening jars, fine motor skills caused pain. Burning pain spread to back, spine, arms. Difficulty moving arms. Pain in injection site continued. Pain along spine from base of neck to waist. Pain moves around. Flashes of pain between toes and along wrists/hands/fingers.  Pain was most severe in September and October of 2021. Gradual improvement since then but as of January 20, 2022, remaining debilitating pain in back, arms, hands, right knee, necessitating a medical leave from work. Patient referred for rheumatology evaluation but will not have first visit until February 2022.
BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Medium, Additional Details: pt's forehead felt cold and sweaty and he tried to lift his legs up and kept his hands high - he described that he faints after a blood taken for a test or after a vaccing, and this might be a mental predisposition to this reaction. we called an embulance, but patient felt better in 5-7 min and requested to cancel embulance. He spent 10-20 min on the chair and felt ok to get up and walk around. He left stating he fill better.
1 days p/vax pt devel an inj site rxn characterized by redness, swelling & warmth which extended to the elbow;pt was seen by MD tx w/unspecified med & recovered;
Developed abdominal pain about a half hour after injection.  Had diarrhea throughout the next 48 hours, fatigue and tiredness for the next 4 days. I was supposed to get my menstrual cycle this past week ( 1 week after injection) and it barely came.  I am 37 years old and I have never had a light menstrual cycle on and off the birth control pill.  This is the first time this has ever happened.
Warm, red, swollen area on right thigh.  Given erythromycin.
None.  Pt sch for autopsy  1/12/09 Autopsy report states COD as: dTGA s/p arterial switch 7/8/08; ventricular hypertrophy; extensive pericardial adhesions; mineralized foreign body w/giant cell reaction; para aortic nodule w/suture; trachea & distal mainstem bronchi discoloration w/frothy exudates. Report also states patient had history of transposition of great vessels comlicated by single intramural coronary arter.  Autopsy revealed nodule located anterior to ascending aorta & posterior to right pulmonary artery.  Histology revealed fragments of mineralized foreign body w/marked inflammatory response of corresponding foreign body giant cell reaction of uncertain significance.  12/23/08 Reviewed hospital medical records of 7/2-7/21/3008. FINAL DX: transposition of great vessels; maternal hx of herpes on Valtrex; PROM; arterial switch procedure 7/8/08; relative adrenal insufficiency resolved; suspected left clavicle fracture; s/p delayed sternal closure; relative lymphopenia resolved.
Left arm deltoid red, swollen and warm to touch. Complaints of some pain to site.
Patient said that the night of the vaccination she experienced some discomfort and pain at the injection site, then the following day the pain continued but the arm was still functional, the following day her arm was very painful and sore and she could barely move her arm. I advised her to see urgent care and let her PCP know. In the meantime she can use some ibuprofen and ice the arm.
Severe pain throughout entire left shoulder and arm, so severe that I went to the ER for treatment, received X-ray, and later MRI when pain did not go away. MRI results indicate tendonitis and bursitis. Going to see orthopedic surgeon on 10/17/15.
This case was reported by a physician and described the occurrence of apnea in a 2 month old male subject who was vaccinated with Pediarix for prophylaxis. On 7/21/05, the subject received the 1st dose of Pediarix (lot not specified). Approximately 1 day later, on 7/22/05, the subject received the 2nd dose of Pediarix to the "right leg". The recommended dosing schedule for Pediarix is 2, 4 and 6 months. On 7/22/05, at an unspecified time after vaccination with Pediarix, the subject experienced "some apnea and bradycardia". The physician also noted the subject's right leg was "tender and swollen after the 2nd dose". This case was assessed as medically serious by mfr. The apnea and bradycardia resolved on an unspecified date in 7/05. The outcome of the injection site tenderness and swelling was not reported. The physician considered the events were probably related to vaccination with Pediarix.
Booster (1/2 dose). Seemed ok next day, but by that night pain in area of kidney. Doesn't feel likey muscle. Thinking maybe kidney. Very painful since (now 4 days). Only on the(my) left side.
A few minutes after injection, patient began to feel faint and dizzy while standing up. Sitting down did not alleviate symptoms of nausea, so patient was moved to a bed to lie down. After about 10 minutes of laying down, patient was back to normal.
Sharp pain in left arm where flu shot was administered. Also, unable to move left arm over head and or to perform activities of daily living without substantial pain.
Report to Dr. 4-16-07 by School nurse that area of injection was red w/swelling.
Patient requested a flu shot at her visit. Patient stated she has never had a reaction to the flu vaccine before. I cleaned the site and injected the 1 in needle and released the medication. The patient's arm instantly started to bubble up. I ask the patient id she was feeling okay, she said she felt fine. I asked her to wait a few minutes so Dr. could evaluate her. Dr. came in looked at injection site asked if she felt okay told the patient if the site gets warm or swells or gets red to come back to office or go to urgent care.
Narrative:  85yo male patient who resided at the Center in HBPC care died on 10/16/2021. His PROBLEM LIST: Decreased vitamin D Transient ischemic attack (5/2019) Serum vitamin B12 borderline low Insomnia Gastroesophageal reflux Dementia due to Alzheimer's disease Copper deficiency Obstructive sleep apnea syndrome Diabetic neuropathy Tinea pedis Impacted cerumen Urinary incontinence Allergic rhinitis Type 2 diabetes mellitus Dyslipidemia Bilateral hearing loss Coronary arteriosclerosis Impotence of organic origin Cataract Pt had received one pfizer vaccines in Jan 2021 from pharmacy store. No other dose reported. Unable to assess if pt's death related to the covid vaccines, However Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccine and date of death.
Caregiver (cg) received Covid vaccine on 1/2/21 @ 0910.  Cg was nervous but did ok with vaccine administration.  Once in the observation area, cg became nauseous and raised her hand to report.  Cg was sitting in one of the back rows so observation RN came to her.  Observation RN was walking cg to lower level when she experienced syncope and fell forward down several steps and to the right hitting the front of her head and right shoulder on the wall.  Cg was unconscious for approximately 30-45 seconds.  Once alert, cg responded appropriately to questions, but slowly.  Vitals were 120/82 P 107 at 0915 and 150/84 P 96 at 0920.  Cg had 2 events of uncontrollable bilateral arm shaking lasting approximately 5-10 seconds.  Rapid Response Code was called and cg taken to ED at 0940.  C-collar and back board was used to transfer cg from floor to stretcher. Unknown at this time if caregiver was admitted.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 9 AM, temperature was 34, total doses given for the day was 188, Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient was injected with an empty syringe that did not contain vaccine. A second syringe with vaccine was injected, and patient's mother believes he was first injected with a used syringe due to a sore arm that was "hard as a rock"
He tested positive for COVID on Saturday and developed sore throat on Monday.  He is able to eat and drink.  He denies cough, shortness of breath, chest pain, fever.