chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash on arm which became infected & devel a boil; 8MAY95 no response to f/u request
tingilling in my right leg was i have 5 stents     and cramp in leg when i walk a distance
Commonly sees swelling after injections; This case was reported by a nurse via call center representative and described the occurrence of swelling in a patient who received Men B NVS BEXSERO for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   The reporter considered the swelling to be unlikely related to Bexsero.  Additional details were provided as follows:  The age at vaccination was not reported. The patient's experienced swelling after injections. The nurse did not have any patient details available at the time of reporting. The reporter did not take the patient's follow up phone call to the office. However, the nurse states if safety wanted to follow up, she would likely be able to gather the patient details if needed. The reporter consented to follow up. This case had been linked to the case US2020202283 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202283:same reporter,specific patient
fatigue, nausea, chills, injection site pain Narrative: Patient had COVID April 2020
Patient was inadvertently given 2nd dose of Moderna 2 weeks early. Patient did not experience any side effects from receiving the dose early.
Starting 2/16/20 eye lids upper and lower began to swell, with redness and itching.  Swelling continued to increase to the point of going for a doctor visit on 2/18.  Diagnosis a possible reaction to vaccine.  Prescribed:  Antibiotic oral, eye ointment, and medrol dose pack ordered.
You get swelled about an hr after vaccination, resolved few hrs later. Parenthesis right hand for two weeks after, especially on right pinky. Vaccination administered on right arm.
gave a 4 month old child an expired Pentacel today with no adverse event; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case received from a healthcare professional (medical Assistant).  This case involves a 4-month-old female patient who received today expired diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel], 242 -pentacel  (expired product administered) (batch number: UJ074AB and expiration date: 13-Oct-2020) at doss of 0.5 ml once via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event expired product administered (latency: same day)  Disclaimer: 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.
Left arm pain, soreness which started on 1/15/03, early AM. Mom gave Motrin. Mom did not look at it until that afternoon/evening. She noticed redness and induration covering an area 10cm X 12 1/2cm on the left deltoid. Pt also had a temperature of 99.1F. On day 2, pt had no complaints of pain and is doing better.
PT RECEIVED MONDERNA AS FIRST DOSE AND RECEIVED PFIZER AS SECOND DOSE.
Patient reported pain, redness, heat, and softball sized swelling around injection site.  She also reported flu-like symptoms.  Patient did not require medical treatment.  Patient was advised to use an ice pack and /or an OTC pain reliever, such as ibuprofen or acetaminophen for reaction symptoms.  Reaction resolved within one week.
PATIENT FAINTED WITHIN 15 MIN OF RECIEVING VACCINATIONS - PT WAS ASSESSED ON SCENE BY ON SCENE MEDICS, THEN WERE CALLED TO SCENE FOR FURTHER ASSESSMENT/TREATMENT. PT WAS TRANSPORTED TO ER FOR ASSESSMENT BY ER PER PT. REQUEST
No additional AE/PQC reported; Improperly Stored PROQUAD was administered to patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) lot # S021326, expiration date 05-JAN-2021 (dose, route of administration and anatomical location were not reported). Administered dose of vaccine was stored in an unknown improper temperature for unknown period of time.  It was unknown by the reporter if there were any previous temperature excursions reported or if digital data logger was involved. There was no additional adverse event reported.
sore arm; This is a spontaneous report from a non-contactable healthcare professional. An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took vicodin and experienced allergy. The patient got her first shot and experienced sore arm on unspecified date, no other symptoms. The outcome of the event was unknown. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
FEVER; VOMITED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and triple stroke in his brain, and concurrent conditions included hypertension, high cholesterol, congestive heart failure, seafood allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 13:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced vomited. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomited on 18-MAR-2021, and had not recovered from fever. This report was non-serious.
Started to have trouble swallowing and lips tingling. Denies trouble breathing. Went home due to slight improvement. Then at about 4/5 pm she tried eating again and had a hard time swallowing and decided to go to ER.
After the first shot, I had what felt like a possible oncoming sinus infection. It felt as though it resolved before the second he room. After the second injection, I began having unexplained neuropathy, a typical facial pain, extreme sinus pressure (no mucus or post nasal drip never presented) and pain without reprieve or medications, myalgia and musculoskeletal pain and disabilities within my joints. Rapid heart rate upon standing or bending to the floor. Weight loss, daily, consistent migraines and headaches, sudden daytime sleepiness. Frequent urination (average 10x an hour if I don?t use electrolytes everyday. Bloodwork shows only that there is inflammation in the body. I have no autoimmune disorder or dysfunction. I had zero prior health problems and was very active and ate healthy foods.  I had to take a leave of absence from work. My condition has disabled me and since I had never contracted Covid-19, i wear N-95s in indoor spaces, and test regularly. I was heavily testing for Covid 19 from February 2021 through April 2021, as I was returning to work for the year.
New onset erythematous and intensely pruritic rash appearing as a hypersensitivity reaction. Extension the next day to about 14 centimeters in diameter. No fever or other systemic findings.
Fever; tiredness; headache; muscle pain; chills; joint pain; This is a spontaneous report from a non-contactable other Healthcare Professional (Patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809), via intramuscular route of administration, administered in left arm on 10Feb2021 at 11:00 AM (at the age of 50-years-old) as dose 2, single for COVID-19 immunisation. Medical history included migraine, hypothyroidism and beta thalassemia. Concomitant medication(s) included levothyroxine (MANUFACTURER UNKNOWN) 100mg; erenumab aooe (AIMOVIG) 70mg. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231), via intramuscular route of administration, administered in right arm on 20Jan2021 at 11:00 AM as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient was not tested for COVID-19. On 11Feb2021 at 10:00, the patient experienced fever, tiredness, headache, muscle pain, chills, joint pain. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
10/1/2016 - Quick to run out of breath at volleyball practice.  Her face started turning noticeably red during physical activity.   11/12/2016 - Basketball season she struggled with the physical activity and running.  Before the vaccine she would run forever without getting tired.
lt leg area swollen @ vax site, started p/inj 21DEC98 throughout the evening & next day;areas red, hot to touch by 25DEC98 areas were back to nl per grandma;
Vomiting and diarrhea started a little over 48 hours post vaccine and still not resolved as of 2/9 at 3:30pm. APRN for resident has been faxed.
No adverse event was reported by patient.  Patient was advised of new protocol/vaccine recommendations that were being updated.  Patient chose to not wait for Prevnar 20 to be shipped and to receive Prevnar 13.  Patient was counseled on the differences between the vaccines and the new guidelines that were being published.  Patient decided they would not wait for the new guidelines and requested Prevnar 13 and to return for Pneumovax according to current protocol on file.
24 hrs- chills, Headache,LA sore, wheezing, fatigue  Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day  Symptoms somewhat controlled with repeated doses of Tylenol and Proair
patient called stating she had covid arm.  bright red band around arm starting 1 week after vaccination and went away in a few days.
Patient received 2 doses of Moderna vaccine:  1/18/2021 and 2/15/2021.   Admitted to Hospital on 4/25/21 for blood in stool. Tested for COVID as part of routine admission testing for COVID-19 on 4/26/21. Patient asymptomatic for COVID-19.
Rashes over abdomen, both legs, both elbows and Hands; Small bumps and redness over rashes; Small bumps and redness over rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes over abdomen, both legs, both elbows and Hands), PAPULE (Small bumps and redness over rashes) and ERYTHEMA (Small bumps and redness over rashes) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced RASH (Rashes over abdomen, both legs, both elbows and Hands), PAPULE (Small bumps and redness over rashes) and ERYTHEMA (Small bumps and redness over rashes). At the time of the report, RASH (Rashes over abdomen, both legs, both elbows and Hands), PAPULE (Small bumps and redness over rashes) and ERYTHEMA (Small bumps and redness over rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is taking blood pressure pill as concomitant medication but not specified. No treatment information was provided by the reporter.
Improvement of Parkinson's symptoms after second dose; Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Parkinson's symptoms after second dose), PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease since 2007. Concomitant products included VITAMINS NOS for Memory impairment, CARBIDOPA and LEVODOPA for Parkinson's disease, GABAPENTIN for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm). On 24-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Parkinson's symptoms after second dose). On 23-Apr-2021, PYREXIA (Fever) and VACCINATION SITE PAIN (Sore arm) had resolved. On 25-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Improvement of Parkinson's symptoms after second dose) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-207601 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up contains  On 26-Jul-2021: Follow up contains
Rash on chest shoulders - itching - all over body swelling under arm on side of vaccine shot. Swelling moved to breast on same side.
Gave Pfizer covid vaccine to under age child.  He is only 11 years.  Notified family.  No adverse outcome as of today
Brusing on Rt arm, several areas, noticed bruses about 2-3 hrs after receiving shot. Bruses are just above elbow and on lower arm on internal aspec of arm.
9MAR98 temp 100-rash hive/like;11MAR98 petechiae abd & trunk;
C/O NAUSEA, VOMITING X 1, LEFT ARM SORENESS, REDNESS AND PAIN IN ENTIRE EXTREMITY, WEAKNESS.
Information has been received from an approximately 56 year old female registered nurse with hypothyroidism, hypertension, and arthritis who in 1988 was vaccinated with the 3 dose series of hepatitis B virus vaccine rHBsAG (yeast).  Concomitant therapy included levothyroxine Na (Synthroid), valsarten (Diovan) and valdecoxib (Bextra).  A titer was drawn in 1996 and 2000 (results not provided), and booster doses were given in 1996 and 2000.  In approximately January 2003, the patient had elevated liver enzymes during routine lab work.  On 01/26/2004, the patient received a third booster dose.  Unspecified medical attention was sought.  There was no product quality complain.  Additional information has been requested.
After first injection, I received daily and weekly surveys.  This time I didn't, this is the reason I'm filling out this form.  This time, about 3 hours after the Moderna injection #2, I started having body aches and general malaise.  The first night I ached so badly, it woke me up.  My fingers and even my butt cheeks were aching.
Pt recv vax on 8/13/95; on same day pt exp hyperbilirubinemia & 7 weeks later dx w/ hepatitis-etiology unknown
Finally you ask!!!! Terrible aches and fatigue on and off for over 7 weeks!!!
I had the H1N1 2009 inactivated vaccine on December 2009. A month later I started developing symptoms of autonomic dysfunction. Initial symptoms included (new onset) post-prandial hypotension, gastrointestinal dysmotility, atrial fibrillation, weakness and impotence. The Atrial Fibrillation required hospitalization for two days in April 2010. These symptoms were then followed by fatigue, postural orthostatism, postural tachycardia, faintness and syncope. The syncope or near syncope episodes required four emergency room visits. The above symptoms progressively worsened but the cause (autoimmune neuropathy) was not found until later. The diagnosis was delayed because cardiac causes where initially suspected. I was diagnosed with "Vasovagal Syncope" by MD after head-up tilt table testing on October 2010. I had also reported postural tachycardia at home to my doctor and this was indeed confirmed much later, in a second tilt table test on March 2011, by another MD. The diagnosis became "Postural Orthostatic Tachycardia Syndrome" or POTS and was attributed to Autonomic Neuropathy of unknown cause. A 30% improvement was achieved with occupational therapy and symptomatic treatment (Midodrine and Metoprolol), but several neurologic sequella remained, manifesting via the above symptoms. The precise cause of the autonomic neuropathy was found in July 2011 with the facility Autoimmune Dysautonomia Evaluation. I tested positive for the Alpha-3 Ganglionic Acetylcholine Receptor Autoantibody. I was diagnosed with Autoimmune Autonomic Ganglionopathy by Dr. at facility. He reviewed that the antibody has been shown to be pathogenic and causative for dysautonomia. He advised that the neurological sequella could respond to immunomodulation via Intravenous Immunoglobulin followed by oral immunosuppressants.
Pt. receives TB skin test on 7-30-07-left forearm. Pt. returned on 8-1-07-test was negative)-no marks on arm. Pt. returned on 8-6-07 with redness, a knot and clean drainage from injection site.
Patient developed severe nausea, vomiting  on day of vaccination and subsequently developed bloody diarrhea. Diagnosed with non-specific colitis. Awaiting colonoscopy,
Pt recvd vax & exp local reactions of pain, swelling & ecchymosis;
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report  was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
gave just the adjuvant; gave just the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27th January 2023) for prophylaxis.   On 27th September 2021, the patient received Shingrix. On 27th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional details were provided as follows: Other health professional reported they had given 2 appropriate doses of Shingrix to 2 patients out of the box of 10 and the 8 remaining doses they gave just the adjuvant solution so they do not remember which of the 10 patient got the full dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported for any patient (as reported). The reporter did not consent to follow-up. Sales representative stated that the health care professional declined follow up the case. This case was one of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021209458:same reporter US-GLAXOSMITHKLINE-US2021209462:Same reporter. US-GLAXOSMITHKLINE-US2021209467:Same reporter. US-GLAXOSMITHKLINE-US2021209470:Same reporter. US-GLAXOSMITHKLINE-US2021209463:Same reporter. US-GLAXOSMITHKLINE-US2021209468:Same reporter. US-GLAXOSMITHKLINE-US2021209482:Same reporter US-GLAXOSMITHKLINE-US2021209478:Same reporter
Reviewed patient's internal immunization screen as well as system. Last Tdap vaccine was listed as 11/14/11. Discussed need for TD vaccine, asked patient if she had received a tetanus vaccine since this time. Patient reports she had not. Pulled TD vaccine, verified need with second RN by reviewing internal immunization screen as well as system. Issued vaccine and administered in EHR. After charting on patient, I noticed a TD vaccine listed from 7/15/2021 on the lower right portion of patient's home screen in EHR. Vaccine was given on 7/15/2021 but was not coded on the encounter for billing; therefore, causing it to not make it on to the internal immunization screen or system. After notifying supervisor, I inputted the TD and Pneumovax 23 in to system that was administered on 7/15/2021 to avoid future duplication of vaccines.