chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme swelling and pain in and around the injection site. Stiffness and pain in the elbow of the arm of injection site. Red, burning extremely itchy rash/hives, spreading from the injection site over the upper arm down to the elbow. Still ongoing 3 days after injection. Open sore at injection site. Treating with topical and oral antihistamines, and antibacterial ointment.
Patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age; A spontaneous report was received from a healthcare professional concerning a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Jan 2021, the patient received her first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The Director of Medical Operations called in stating that it was reveled on 12 Jan 2021 that a patient in his clinic received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age. The administration was made in error.    Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event, patient received the first dose of the Moderna COVID-19 vaccine that was under 18 years of age, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
High fever 102 degrees, about 3 days.  Vomited, about 11 PM.  Shot was 3:00 ish. Body ws inflamed w/ redness about 3 days, eyes sunkin in.
second dose more than the recommendeed time interval/gap; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (second dose more than the recommendeed time interval/gap) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (second dose more than the recommendeed time interval/gap). At the time of the report, OFF LABEL USE (second dose more than the recommendeed time interval/gap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  No treatment medication was provided
Joint pain, headaches, exhausted, chest constriction, sweats, treatment aleve, & excedrin & SLEEP
My husband and I received a vaccine of Td and Tdap on 10/1/2009, he has a reaction to vaccine Td and Tdap,reaction appeared on the skin (not under the skin)pockets of large fluid bubbles around the site,(with pain) is this common?
Immediately following my shot I felt brain fog and dizzy but continued with my day. The next morning I woke up with extreme nausea and a migraine. I am prone to migraines. I was hot and chilly but never read a fever. It's hard for me to sleep due to discomfort.
shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
This spontaneous report as recovered from a nurse refers to an unspecified number of patients of unknown age and gender. On an unspecified date, the patients may have received improperly stored od PEDVAXHIB intramuscularly (dose and lot number were not reported). The vaccines were improperly exposed to 48.5F for 5 hours 49 minutes (on 01-FEB-2015), and to 48.5F for 9 hours 44 minutes (on 02-FEB-2015), and to room temperatures <77F for 31 minutes (on 24-FEB-2015) for 16 minutes (on 16-FEB-2015) for 15 minutes (on 09-FEB-2015) for 15 minutes (on-FEB-2015) for 24 minutes (on 30-JAN-2015) for 31 minutes (on 27-JAN-2015) for 40 minutes (on 15-JAN-2015) for 16 minutes (on 06-JAN-2015) and for 54 minutes (on 30-DEC-2014). There was no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient tested positive for COVID despite 2 doses of vaccine.  Symptoms started 4/27/2021.   Patient reported body aches, headache, and nasal congestion.
12/31/2020 @ 0700- Client awoke with stuffy nose and "did not feel right". 1/3/2021- Starting in AM: Headache and fatigue that are continuous.  Taking Tylenol, Excedrin, and Advil PM. 1/7/2021- Advised client to get Covid Testing and go to Urgent Care, as she has no PCP at this time. 1/7/2021 @ 1230- Client states has Covid test scheduled at 1430 today at Urgent Care.
It was reported that a 25 year old male pt received a Menomune A/C/Y/W-135 vaccination on 2/7/00 at 12:00. Reportedly, at 12:10, the pt stated he felt lightheaded, fell forward and the left side of his face hit the floor. The pt experienced a brief loss of consciousness, ammonia inhalant was effective. The pt lost a left upper tooth, had an abrasion and swelling of left cheek, abrasion of chin on left side and a small amount of blood in mouth. The pt had no recall of passing out. The pt was awake, alert, oriented, BP 162/84-164-20, rechecked 10 minutes later and BP 156/86-150-20. "I feel okay", pt sitting in chair, was given juice and remained oriented. The pt was instructed to see family doctor. Reportedly, the pt recovered from this experience. On 5/17/00, an error was amended in the actual onset time of the adverse event. The correct time was 12:10, not 12:02, as previously reported.
Case number PHEH2016US023431, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 27 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 18 Feb 2016. On 18 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the nurse.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Additional Details: I have been observing patient for 30+ minutes. Patient is feeling better after drinking a bottle of apple juice. It has been about 40 minutes now and patient said she is feeling back to normal 99%.  She said she wants to go home herself.    I had the nurse from the  minute clinic check her blood pressure and systolic was 158. Patient does have hypertension and takes 2 blood pressure medications. Patient does not have pain at injection site, the system made me select something
At the time of vaccination, there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home where patient was a resident.  About a week later, patient tested positive for COVID 19.  She had a number of chronic, underlying health conditions.  The vaccine did not have enough time to prevent COVID 19.  There is no evidence that the vaccination caused patient's death.  It simply didn't have time to save her life.
Fever, headache, flu-like symptoms, wheezing, respiratory difficulties, fatigue x 1 week.
4cm red raised warm reaction on upper L arm.  No fevers.  A little itching at site.  No vomiting or resp symptoms.  Symptoms noted about 20 hours after injection.
Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.).    No concomitant medications were reported. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-644874 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644874:
This spontaneous report as received from a nurse refers to a patient of unknown age. No medical history or concurrent conditions were reported. The patient was vaccinated intramuscularly with VAQTA on 18-JUN-2012. No lot number was reported, No other co-suspects or concomitant medications were reported. On 04-OCT-2012 the patient was administered with the booster dose. No adverse events was reported. No further information was provided. Additional information has been requested.
pt recv vax & devel fever of 105-106 & fever subsided p/Motrin;pt stopped progressing developmentally;pt no longer sat by self & did not crawl until a later than expected date;
On 6/26/00, the pt received his first IM - left deltoid dose of Lymerix. Within one week post vax, he experienced severe left shoulder pain and swelling. During the first few days, the pt "could not move" his shoulder. He can move his shoulder now but has constant pain. He thought it was more muscle pain than joint pain. An MD visit was required and the pt was treated with an analgesic/anti-inflammatory combination. The pt had difficulty identifying whether his pain was in the shoulder joint or in the deltoid area of his left arm. He was unable to determine whether the pain was myalgia or arthralgia. He reported that on a scale of 1-10, his pain was a "9" in the mid-day to evening and a "3" in the morning. He reported that his pain was worse if the weather changed to rain. He reported that the pain is primarily "in his shoulder". He was seen by a physician about 5-7 days after the pain started. He reported that his physician noted redness and swelling and the diagnosis of bursitis was given. His joint complaints have been evaluation by a physician. A swollen left shoulder joint has been documented on physical exam. Joint fluid was not obtained. On FU pt states within 2 hours post-vaccination he experienced severe left shoulder pain and swelling. He was "almost totally immobilized for about a week or two thereafter.  The pt reported that the physician wanted to treat the pt with cortisone injection, but the pt declined. The pt took the meds for one week but discontinued it as it caused drowsiness and nausea. As of 8/02/00, the pt reported that there had been slow and gradual improvement and he can extend his left arm "up to shoulder level" but it continued to be painful. He was unsure if there was redness or swelling now.  The events of left shoulder pain, left shoulder swelling, bursitis, and shoulder stiffness do not meet ICH serious criteria, but are being submitted expeditiously for information purposes.
Employee received MMR vaccination on 5/23/07. She reports increasing fatigue and "listlessness"  from 5/25 to 6/5/07. On 6/5/07, she reports achy joints and flu-like symptoms and the onset of a non-urticaric rash on her left arm that spreads to her chest.
Developed redness, swelling, itchy to the area, was seen in ER given Benadryl, Prednisone and Provenil  in house.
This spontaneous report as received from a physician refers to a 34 year old female patient with allergy to azithromycin and migraines. In 2006 the patient was vaccinated with VARIVAX (merck) (lot# and route unknown). No other co-suspects were reported. No concomitant medications were reported. Physician reported that a patient received two doses of VARIVAX (merck) "four weeks apart" on an unspecified date. Physician reports that titers were drawn on 12-MAY-2013 and resulted "low". The physician reported that the patient was administered the two doses of VARIVAX (merck) in 2006 at a different physician's office and the reason the patient received the two doses of VARIVAX (merck) was due to the patient having negative titers at an unspecified time that was prior to the administration of the VARIVAX (merck). It was unknown if the patient had sought medical attention. The outcome was unknown. Action taken was not provided. Additional information has been requested.
2 hours after vaccine administration, patient reported acute chest pain and facial numbness/tingling. Patient went immediately to the Emergency Room where she had a normal EKG, CBC, and CTPA. Patient had an elevated D-Dimer but normal ESR and CRP. Patient was diagnosed with a hypersensitivity reaction to the vaccine.
Information has been received from a registered nurse concerning a patient who was vaccinated with PNEUMOVAX 23 and experienced adverse events. The patient had injection site reaction that looked like cellulitis. The patient had sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow up information received from a registered nurse indicating that the 65 year old female patient with no illness at time of vaccination and no known drug allergies, on 04-SEP-2009 at 9:34 am was vaccinated with a dose of PNEUMOVAX 23 (lot # 662598/0466Y) IM in the left arm. Subsequently, on the same day the patient experienced site pain and "arm feels stiff". There were no breathing difficulties, no fever and no redness or swelling at site. The patient "felt better today (05-SEP-2009) than yesterday". There were no labs and diagnostic tests performed. The patient recovered on an unknown date. This is one of several reports received from the same source. No further information is available.
I smell and taste smell like rotten fish; I smell and taste smell like rotten fish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autoimmune thyroiditis" (unspecified if ongoing), notes: Verbatim: Hashimoto's disease. Concomitant medication(s) included: LEXAPRO. The following information was reported: PAROSMIA (non-serious), TASTE DISORDER (non-serious), outcome "unknown" and all described as "I smell and taste smell like rotten fish". Therapeutic measures were not taken as a result of parosmia, taste disorder.  Additional information: The due date of second dose of vaccine consumer stated, 29Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  PER DEATH CERTIFICATE/CHART REVIEW, CAUSE OF DEATH WAS COPD. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine.
Stabbing pain in his back; he can barely walk because of his pain; This spontaneous case was reported by a non-health professional and describes the occurrence of BACK PAIN (Stabbing pain in his back) and GAIT DISTURBANCE (he can barely walk because of his pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BACK PAIN (Stabbing pain in his back) and GAIT DISTURBANCE (he can barely walk because of his pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Stabbing pain in his back) and GAIT DISTURBANCE (he can barely walk because of his pain) had not resolved.            The reporter confirmed the patient does not take any concomitant medications.
About 10am started having chills and fever, took 2 tylenol 10:30-11:30am - threw up 4 times 11:30-230pm - fever and chills, headache 5pm - fever and chills stopped Very low energy thru Friday 3/26
extreme muscle pain w/in 2 hrs of immun; muscle pain & burning sensation is acute & debilitating w/no relief; various MD have made various dx & varied treatments w/no relief;
I had a breakthrough infection on 10/17/21 and have swollen tonsils and still have it to this day and I have been to the ENT physician and they say there is no treatment for it.
Red, warm and itchy to injection area.  Taking Claritin and can take OTC Benadryl and apply ice.  Given Ibuprofen.
in mid/late January, I developed overactive bladder issues. Sudden onset of needing to urinate despite not drinking a lot of liquids. I go from not needing to urinate to uncontrollable urge in as short a time as 2 seconds. The overactive bladder has worsened over time. I do not have any other symptoms that would suggest a UTI. However  I have seen recent articles about COVID causing an overactive bladder so I decided to report, even though I have never contracted COVID (I have been taking a PCR test weekly since September 2020).
Pt went pale then began to have a seizure.  No incontinence - decorticate posturing witnessed.  No change in HR but RR went to 4/min.  After approximately 5 minutes - patient awakened - a/o X4.  Pt c/o tingling in hands/feet.
Per mom, pt had "baseball" size raised, red area on Lt leg. "This went away in three days."
CDC reports: 7 mo infant developed fever to 102 & rash same day of immunization. Rash resembled erythema multiforme & lasted 1 day.
This is a spontaneous case, initially received from pharmacist on 21-Nov-2018, concerning a 64-year-old (reported as 64 and a half), adult female patient. The patient had no relevant medical history or concomitant medications. On 20-Nov-2018, the patient (under 65 years) was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250793 and expiry date: 30-Apr-2019). The patient did not experienced any adverse events. The reporter assessed the case as non-serious.
A report has been received from a Health Professional concerning a patient, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Health Professional reported that they administered expired FLUMIST QUADRIVALENT to 11 patients. The outcome of the event expired FLUMIST is unknown. The report was considered to be non-serious.
physical disability, couldnt use arm lt-arm was limp and fixed at the same time, neurological problems, severe memory loss, depression, anxiety, hard to breathe, hallucinations, sleep apnea
Developed symptoms of Covid 19 4/12/2021 including congestion, headache, and loss of taste/smell and tested positive 4/18/2021.
3 Tonic Clonic seizures on 7-6-2009 12 hours of Tonic Clonic seizures on 2-12-2010
lip swelling; tongue swelling; This case was reported by a physician via call center representative and described the occurrence of lip swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anaphylactic reaction, swollen tongue and lip swelling. Concomitant products included prednisone.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced lip swelling and swollen tongue. On an unknown date, the outcome of the lip swelling and swollen tongue were unknown.   It was unknown if the reporter considered the lip swelling and swollen tongue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional calling regarding a female patient in her seventies. The patient had a history of experiencing anaphylactic reactions with tongue and lip swelling. On an unknown date 5 months ago the patient received her first dose of Shingrix and approximately 30 days later she developed tongue and lip swelling no larynx involvement. The patient was treated with a 4 day course of prednisone and the events resolved. No emergency care was needed and no use of epinephrine. The reporter did not consent to follow up. The reporter did not had all the dates, treating physicians names, patient demographics.
This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees F for 30 minutes on 03-FEB-2017. No previous temperature excursion occurred. No product quality complaint was involved. No adverse effects were reported. Digital Data logger was involved. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1704USA010916: Original Case : 1704USA010916