chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Same day symptoms included Headache, injection site soreness, fatigue and muscle aches and pain through out body.   Symptoms lasted 2 days; On 5th day, started feeling nauseous and 8pm started feeling acute abdominal pain with increased intensity.   8:30pm abdominal pain continued with pressure in back and chest.   Then wife took me to ER.   Exams (CT Scan, bloodwork and vitals) were taken but was all normal.   At 2am abdominal pain went away but discomfort in abdominal area continued.   I was released at that time.   On 7th day had follow up with primary care physician and they reviewed documentation from Hospital and determined that I experienced symptoms from covid vaccine.
Patient presented to pharmacy the day following injection with complaint of redness, swelling, and pain in the arm around injection site. Patient reported on 9/10/2020 that the swelling and redness has improved and she is not having much pain.
Numbness, nerve root inflammation, Ulnar neuropathy of upper left extremity and Myositis of left shoulder (unspecified).  Constant aching of left arm, burning/stabbing, sharp pains intermittently. Range or motion reduced to under shoulder level.  NOTE: left hand writer.
five year old female patient received doses of Ipol,and Kinrix vaccines  with no reported adverse event; Initial information received on 09-Aug-2021 regarding an unsolicited valid non-serious case from a pharmacist via Global Medical Information (Reference number- 00716202).  This case involves a five year old female patient who received vaccines IPV (VERO) [IPOL] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [KINRIX], which was double dose of the polio vaccine (extra dose administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 09-Aug-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot number and expiry date: not reported) (Frequency: Once) via an unknown route at an unknown administration site for prophylactic vaccination.  On 09-Aug-2021, the patient received a 0.5 ml dose of suspect KINRIX not produced by Sanofi Pasteur (lot number and expiry date: not reported) (Frequency: Once) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported that "she asks what to do about the patient receiving a double dose of the polio vaccine and what side effects that a 5 year old patient might expect. Unable to find this information in the standards or PI (prescription information)".  At the time of report 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 the 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.  There will be no information available on the batch number for this case.
Patient was given a MENACTRA inj in (L) deltoid. There were no signs & symptoms when she exited clinic. Client called 2/7/2013 - stating she had a red raised reaction size of quarter. She called her physician & he instructed her to contact us.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium
Fever  and moderate headache off and on for first 24 hours.    Hot flashes starting day 2 around 1pm off and on.   Rapid heart rate with chest pressure and sweating  (measured 129) at about 5pm day 3. Lasted 25 minutes.   Severe irritability at about 8am day 3 and ongoing
I feel itchy all over from head to toe. There is a slight warming sensation and tightness of my skin. There are no bumps or rash. It feels like a similar reaction I have to penicillin before the hive appear.
consumer reports that following a finger injury, recv stitches & TD vax;pt devel a huge knot w/a black circle around it @ inj site;inj puncture became larger & fluid spontaneously drained from it;
Information has been received from a nurse concerning a 60 year old female who on 21-OCT-2006 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 Lot # 651399/0486F).  Concomitant therapy included influenza virus vaccine (unspecified).  On 21-OCT-2006, post vaccination, the patient experienced nausea, chills, shivering, weakness and developed soreness, swelling and redness at the injection site.  The patient sought unspecified medical attention.  At the time of this report, the patient's nausea, chills, shivering, weakness and soreness, swelling and redness at the injection site persisted.  Additional information has been requested.
pt had rash that itched; examined rash w/student looking in mirror; fine, clustered raised rash noted around nose & forehead;
pt recvd vax 6APR95 & discovered p/vax to have transiently elevated liver enzymes on pre-admission testing for kidney tumor surgery;
PATIENT STATED THAT 1 WEEK AFTER THE VACCINE HE IS EXPERIENCING SEVERE FATIGUE AND SPENDS MOST OF THE DAY SLEEPING. HE ALSO HAS EXPERIENCED CONFUSION
After Moderna Covid vaccine injection #2  sick for 2 days, including Tinnitus in right ear and vertigo, intermittent headaches.  Also for 3 days had a burning rash in left arm from injection site down to wrist skin "appeared scaly in red form", but was not, resolved after 72 hrs. Have had the other symptoms ever since. Following Moderna booster on 10-24/21, increased Tinnitus, vertigo and injection site remains a 4×3 inch square of inflamed, red raised skin incredibly painful to the touch.
Low grade fever and chills starting around 12hrs after vaccination. Chills lasting for ~6hrs (subsided with Tylenol). Low grade fever, intense confusion, fatigue intense body aches continued until 36hrs after vaccination.
pt recv vax 10OCT96 & was hosp & dx of GBS on 30DEC96;No further information was available @ the date of this report;this is a serious, labelled event;It is being submitted in a 15-day time frame was requested by FDA;
Mild to moderate flu-like symptoms five hours after injection; relieved with OTC ibuprofen. Moderate flu-like symptoms new onset 26 hours after vaccine administration, not relieved by ibuprofen. Extreme fatigue, mild chills, mild fever, slight cough.
could barely lift the arm; left arm was numby; not been feeling well; left arm was achy/ aching legs and arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset Mar2021, outcome "unknown", described as "could barely lift the arm"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was numby"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "not been feeling well"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "left arm was achy/ aching legs and arms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was administered the Pfizer bivalent as the primary series.  No adverse reactions were reported.
Patient came into store and reported injection site reaction and infection on 9/18/2020.  The area was about 4x4 inches and was raised, red, and hot to the touch.  She had been to Physician and was prescribed Clindamycin to help with an injection site infection.
Pt devel continuous dull pain in lt shoulder 1 wk p/MMR recvd; pain centered in trapezius & supraspinatus; No neck pain; no relation to movement; pain goes down lt arm; ER dx toxic neuritis probably due to vax;
110.kg 5'3" 63 yo F was given a Moderna "booster vaccine (0.25ml) at 1135 and was observed for 30 minutes due to previous reactions to Shingrix and Flu vaccines.  At 1210, the patient complained of diffuse pruritis and "hot" skin. No other symptoms.  VSS.  Patient reports that she usually takes one "Benadryl" when this happens with other vaccines.  MD consulted and agreed with po diphenhydramine which was given.  After an additional 15 minutes of observation, the patient reported resolution of symptoms and was discharged.   Previous doses given 3/13/21 and 4/15/21.
Irregular menstrual bleeding starting in the middle of birth control pill cycle (spotting with increased flow for 14 days), headaches/migraine, fatigue, joint pain (left knee and right fingers), blotchy discoloration and veins can be seen in a "lace-like" pattern on the back of both legs, some sharp pains in lower leg especially at night, return of rash/inflammation on arms particularly on right arm.   Went to a clinic on 4/12/21 to ensure discoloration on legs was not a symptom of blood clots since my primary Dr. had to move my appointment out a week. Determined discoloration was not a concern and gave me a prescription for migraines. I have not taken the migraine medication as of 4/26/21.  Primary Dr. appointment on 4/19/21. Determined symptoms were not a side effect of the birth control, but possibly the COVID vaccine. Ordered blood work. As a result, a CT chest scan was ordered due to high D-Dimer test results which was completed on 4/20/21 at the Hospital to check for PEs. Was also instructed to stop taking the birth control (still currently not taking ad will not start taking again). Follow-up with Dr. on 4/23/21 CT scan came back normal, but following up with additional blood work and ultrasound of both legs (scheduled for 4/26/21) to determine what the issue could be. Follow-up to discuss results scheduled for 4/28/21. Instructed to postpone second dose of COVID vaccine and take one baby aspirin a day.
pt described menthol-like taste in mouth during administration of vax;c/o throat tightness & burning;pt observed for 1/2hr;condition improved;no other intervention given;pt advised to f/u w/pvt MD;
Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency.
Large redness and swelling at injection site with induration 8cm X 4cm; redness 1cm X 5cm on left thigh.
On 5-13 - PREVNAR administered. 5-19 - pt showed up and showed arm 5" x 5" redness in area of shot and spreading. 5/21 - went to MD and got on BENADRYL 1 on 5/26 - all symptoms gone.
Total body arthralgia with arthritis R>L hips and R>L knees lasting 9 days.  Unable to walk 100 feet to car to go to work for 2 days--severe limp for 4 days.
Received Rotateq vaccine on 1-23-07 and 3 D later had developed enough sxs that mom brought her into the clinic. She was diagnosed with bilateral otitis media. Mom read in manufacturer site that this was a possible side effect.
Menveo which is a vaccine for meningococcal infection has a 2 vial dose. One with liquid and one with powder. My son only received the liquid portion for the vaccine. The nurse who administered the vaccine realized shortly after that she made the mistake of not giving both vials at once.
Started falling asleep at the table; Slurring of speech; Memory Loss; Unstable; Fever 102.5F; NAUSEA; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Unstable), SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech), AMNESIA (Memory Loss) and NAUSEA (Nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2020, the patient experienced NAUSEA (Nausea). On 26-Jan-2021, the patient experienced PYREXIA (Fever 102.5F) and NAUSEA (NAUSEA). On 27-Jan-2021, the patient experienced FEELING ABNORMAL (Unstable). On 30-Jan-2021, the patient experienced SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech) and AMNESIA (Memory Loss). On 28-Jan-2021, NAUSEA (NAUSEA) had resolved. At the time of the report, FEELING ABNORMAL (Unstable), SOMNOLENCE (Started falling asleep at the table), DYSARTHRIA (Slurring of speech) and AMNESIA (Memory Loss) outcome was unknown and NAUSEA (Nausea) and PYREXIA (Fever 102.5F) had resolved.        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 medications were reported.  No treatment medications were provided by the reporter.
Morning p/immun, infant was found dead in her crib by babysitter, infant was blue, pulseless & apneic; transported by Ambulance to ER & pronounced dead; Cause-SIDS no sx to immun as fever or irritability, appeared healthy;
This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown, which was stored at -6.66 Celsius Degrees for 480 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: L PRED; SERTRALINE; METFORMIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: The patient received other medication in 2 weeks. Anti-viral details: COVID 19 treatment with Paxlovid from 15May2022 to 19May2022. The patient experienced rebound infection 25May2022 and no treatment was received for the event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I got chills; mild headache and just tired. It lasted and then I got sick on the 1st; Got tested for COVID January 3rd, 2021; On January 1 mild headache; tired and very congested but then real runny nose (went back and forth).  On January 2, I got a fever - 101. Took Tylenol. On January 3, I got a fever. I was taking zinc; vitamins. My doctor prescribed medicine but I only took it twice as I didn't like how it made me feel - made it feel like I had something in back of my throat. I still have headaches - they aren't going away and neither is the tiredness. Yesterday, I woke up fine - but when I was at work started feeling very tired; and headache was so bad it felt like eyes were burning. Today I had a mild headache. I was staying at a hotel until the tests for COVID came back negative. I normally don't have headaches and fatigue.
48 hours following Tdap patient developed dysphagia and went to Urgent Care. She was given an injection of a steroid and observed, sent home with oral steroid and (2) EPI-PENS. Patient also had a papular rash on (RT) shoulder and arm.
Large erythematous, non-painful, warm area on (R) deltoid with mild swelling, measuring approx 12 cm x 6 cm.
I started to have numbness on the right side of my face near my nose. I woke up the next morning and my face was dropping on the right side. I had difficulty speaking, and my tongue felt numb and had a burning sensation. I noticed when I smiled the right side of my face didn't move. When I closed my eyes, the right eye did not stay closed. It became difficult for me to speak. Within a couple hours I went into the ER. I was diagnosed with Bell's Palsy. I was given prednisone. I went and saw my primary doctor a few days later and was given anti-viral medication.
was given vax & next day devel local react erythema, induration w/no tenderness just around & below inject site;
No adverse event; Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)).    No concomitant medications were reported.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose.  It was unknown if patient experienced any symptoms after getting the vaccine.  No treatment medications were reported.
R deltoid with 5 x 5 cm red area, no tenderness, no warmth
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization - NSTEMI/Myocarditis Patient received Pfizer Vaccines on 2/2/2021, 2/23/2021, and 10/6/2021. Presented to ED on 10/8/2021 after developing chest pain. Patient reports shoulder/neck pain started on 10/7. EKG demonstrates nonspecific ST abnormalities in lateral leads. Labs were notable for Trop 0.12 > 0.15 > 2.66. LHC reported Incidental finding of chronic total occlusion of mid circumflex in the setting of acute myopericarditis associated with COVID-19 vaccination. Echo reported EF 55-60% and grade 2 diastolic dysfunction. Patient diagnosed with Myocarditis from Acute COVID Vaccination. Patient discharged on ASA 81mg, Metoprolol 25mg BID
Moderna COVID-19 Vaccine EUA   Tingling in fingers of vaccine Friday evening, more pins in needles all over body gradually growing throughout weekend However, real pins and needles did not start until Sunday night while sleeping all over body Difficulty walking on Monday, couldn't move legs well   Currently still have pins and needles all over body and some stiffness...
1.  HEADACHES every day that are sharp and variable in location and come and go all day.  Getting less intense with time.  Associated symptoms similar to a TIA.  On date of  injection she felt DISORIENTED.   She has been feeling nauseous and and with intermittent chills.  All symptoms continuing as of office appt today 3/30/21
it looked like what I've heard shingles looks like.  My urgent care clinic appt on 3/20/21 confirmed this suspicion; Eight days after getting my 1st Pfizer vaccine, i noticed a rash on my torso (3/19/21).  Tho i've never had it before, it looked like what I've heard shingles looks like.  My urgent care clinic appt o; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 67-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: en6206), via an unspecified route of administration (at the age of 67-years), administered in Arm Left on 11Mar2021 15:15 as dose 1, single for COVID-19 immunization. Medical history included known allergies from sulfa and Take meds named earlier for depression; that's all. Concomitant medications included venlafaxine, levothyroxine, cyanocobalamin (B-12) , aspirin [acetylsalicylic acid] (low-dose ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took thimerosal and experienced known allergies. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 14:00, the patient stated that eight days after getting my 1st Pfizer vaccine, I noticed a rash on my torso (19Mar2021), though I had never had it before, it was looked like what I had heard shingles looks like. My urgent care clinic appt on 20Mar2021 confirmed this suspicion. I began taking Valacyclovir that afternoon/evening but could not tolerate it so, after a call to the urgent care clinic, I switched to Acyclovir, which I will be on till 31Mar2021. The treatment was received for the adverse event with valacyclovir and acyclovir. The adverse event result in Emergency room/department or urgent care. The facility most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The clinical outcome of the events was reported as recovering.
pt recv vax 12MAY94 & 25MAY94 pt exp sx of thrombocytopenia;hospitalized several times; therapy immune globulin; pt unable to maintain adequate platelet count
11/11/09 am started having pain and vision loss in R eye.  11/12/09 saw eye doctor. 11/12/09 saw ophthalmologist 11/17/09 saw ophthalmologist and neurologist 12/2/09 saw neurologist - looks better 12/3/09 doc - vision better may not come back 100%. Getting better, not 100%