chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 day p/vax pt devel swelling at inj site of Tetanus vax.Pt exp mild arthralgia tx w/ibuprofen.08/13 pt devel 7 inch area urticaria,pain & itching @Tetanus site.
Patient reports Swelling of arm of injection site, induration, redness and  itchiness at site.
One day after vaccine joint pain, headache, chills, fatigue and  6 inch by 6 inch painful/ red/ hot area on arm below deltoid (looks like cellulitis reaction)
Pt. experienced redness near injection site. Swelling of (L) arm and unable to move arm or raise it (can't get dressed).
Moderna COVID-19 Vaccine EUA: patient hospitalized for recurrent pleural effusion and COVID-19 infection with decompensated cirrhosis,  pancytopenia, and acute kidney injury. Received remdesivir, steroids, and diuresis. Discharged to home medically stable.
Had Hep B #2 at 5:30, then while at karate lesson, became dizzy, nauseous, & had trouble catching breath. Did not call medical assistance. Did not take any meds. Was able to eat and drink, no further nausea, no vomiting. Returned to school next day.
After a bath several red bumps were noted on trunk, neck and back.  That evening bumps looked fluid filled and noted more spots.  No fever or other complaints.  A few new spots on head and limbs the next morning.
Pt experiencing intense itching on eye and on body. Pt said symptoms began after vaccination (June 4, 2021-4 days), has been taking Benadryl nightly since but has had no relief. No reaction was noted during 30 minute period after vaccine and pt stated that itching began at home that night. Pt unsure if eye itching is associated with hitting face on rope by accident, but entire body itching continues. Pt told to go to clinic and advised to make appointment with PCP.  Pt refused referral for prompt care due to cost of care.
Information had been received from a medical assistant concerning a 65 year old female with hyperthyroidism, coronary artery disease, hypertension, diabetes, diverticulitis, hyperlipidemia, asthma, osteoarthritis, carpal tunnel syndrome and gout who on Nov 18 2005 was vaccinated IM in the right arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included influenza virus vaccine (unspecified) (left arm), calcium carbonate, bisoprolol fumarate, lansoprazole (Prevacid), Candesartan cilexetil (Atacand), aspirin, allopurinol, prednisone, atorvastatin calcium (Lipitor), vitamins (unspecified), amlodipine besylate (Norvasc) and metformin. On Nov 21 2005, the patient presented with pain, redness and swelling in the right arm, and felt sick, warm and tired. The patient was treated with ice compresses to the deltoid muscle and acetaminophen (Tylenol). On Nov 30 2005, the patient was seen in the physicians office, and reported that she felt fine. The reporter considered pain in extremity, feeling hot, malaise, fatigue, erythema and peripheral edema to be other important medical events (OMIC). Additional information had been requested.
anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the third of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Pt seizured w/106 temp; 28 days p/immun w/ear infect & ulcers in mouth & throat;
Covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to MODERNATX, INC.-MOD-2023-694625 (E2B Linked Report). This case was linked to MOD-2023-694616, MOD-2023-694621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live follow-up received contains no new information; Sender's Comments:  MODERNATX, INC.-MOD-2023-694625:Daughters case
Patient reported swelling within a few hours of receiving the vaccination. Swelling started at injection site and continued down arm and into hand and fingers. Patient went to the emergency room to see physician. Patient was sent home in an arm sling. Unknown what the emergency room physician instructed patient to do.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, route of administration, lot# and expiration date were not provided). No adverse effects were reported. Temperature and time frame: 32 degrees Fahrenheit to 35 degrees Fahrenheit for 67 minutes and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 139 minutes. Previous temperature excursion?: No. Was call because of a "data logger"?: Yes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA013411: US-009507513-1709USA000879: US-009507513-1709USA000880.
the patient received first dose of Shingrix and on an unknown date developed shingles after receiving the Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist had no further information of when the patient developed the shingles, the resolution, lot number, or route. Did not consent to follow-up.
VACCINATION ADVERSE REACTION; This spontaneous report received from a patient concerned a 46 year old of unspecified sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (oral, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. 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 an unspecified date, the subject experienced vaccination adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination adverse reaction. This report was non-serious.
Fully vaccinated (not up to date) patient who admitted to hospital with COVID detected test.  Provider discharge note below:  "47-year-old female who presented to the ER with chest pain.  She was found have an acute STEMI with troponins increasing from 16-638. Patient was transferred to Facility and underwent cardiac catheterization.  Patient did receive a drug-eluting stent in the RCA and was started on aspirin and Brilinta for 1 year. Metoprolol succinate 25mg daily added on discharge. Echo at this time showed preserved ejection fraction at 50-55% without segmental wall abnormality without significant diastolic dysfunction as well.  Patient did not have signs of heart failure. Lisinopril 2.5mg daily added as well. Patient did have hyperlipidemia in the past with an LDL of 127, and total cholesterol of 226.  Recommend redraw all outpatient the patient was started on empiric Lipitor 40 mg daily. Patient did test positive for incidental COVID during this time and did have fever after catheterization.  Patient was otherwise asymptomatic and did not require increased oxygenation although she does use 3 L at night regularly.  Patient was worried about home mobilization and home care was ordered.  Patient requested to follow-up with Dr. an appointment made on March 31, 2022. "
This spontaneous report as received from a pharmacist refers to a patient od unknown age and gender. On 09-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX23 (strength, dosage and route unknown) lot # K004148, expiration date: 10-MAY-2014. On unknown date in September 2014, the patient had a fever and had soreness at injection site after receiving the PNEUMOVAX23. The reporter stated that the patient had to leave work due to injection site being red and inflamed and Pharmacist was requesting a lot check on lot#K004148 exp. 10-MAY-2014. This is one of several reports received from same reporter. Additional information has been requested.
Pt developed fever and flu-like symptoms post vax. Pt developed erythema to site. She was instructed to take Advil and return to MD for lab draw.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA. The manufacture provided 0.5mL per vail instead of 0.25mL per vail.
sweating it hurt so bad; sweating it hurt so bad; he would notice it and stats it did not hurt but was an "awkward feeling", but today reports even more of an improvement. He states "it's gone."; That night the caller couldn't get that tooth ache pain; 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 43 year-old male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation; paracetamol (TYLENOL) (Batch/Lot number: unknown) for toothache. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN taken for toothache. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 24Apr2021, outcome "recovered" (25Apr2021), described as "That night the caller couldn't get that tooth ache pain"; PAIN (non-serious), HYPERHIDROSIS (non-serious), outcome "unknown" and all described as "sweating it hurt so bad"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 25Apr2021, outcome "unknown", described as "he would notice it and stats it did not hurt but was an "awkward feeling", but today reports even more of an improvement. He states "it's gone."".  Additional information: Patient reported that he had a toothache on the right side of this mouth since last July that he had been treating with Ibuprofen 400mg twice daily and reports that initially after taking the second dose of the vaccine, no matter what he took medication wise, the toothache pain would not go away. However, he stated that the next day and every day he had not had to take anything for the toothache and reported that it's "almost as if it has disappeared." He also reported that yesterday if he were to touch it, he would notice it and stated it did not hurt but was an "awkward feeling", but today reported even more of an improvement. He stated "it's gone." He mentioned that he had no negative side effects with the vaccine and offered to had blood work done if Pfizer was interested in his case. On Saturday, 24Apr2021, the patient received the second dose of the Pfizer covid vaccine. That night the patient couldn't get that tooth ache pain to stop, he was sweating it hurt so bad. The patient took Ibuprofen and Tylenol and it didn't help with the pain. Every day after that incident, the patients tooth ache had been gone. Prior to this event the patient couldn't bite down or drink cold water on the right side of his mouth where the tooth ache was. Every day he was experiencing the tooth ache pain prior to this event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 8/12/21 at 8:30 p.m. resident noted in bed alert and responsive.  Resident noted talking to nurse.  At 9:10 p.m., resident noted to be unresponsive by staff.  CPR initiated.  911 arrived at 9:27 p.m. and was unsuccessful.  Pronouncement of death at 9:30 p.m.  Medical examiner deemed resident death as natural causes
gout; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) via an unspecified route of administration, in the left arm on 18Mar2021 at 12:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease. Concomitant medications included levothyroxine sodium (SYNTHROID), from unknown date and for unspecified indication. The patient previously received Ibuprofen on unknown date and for unspecified indication and patient experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021, approximately five days after receiving the vaccine, the patient experienced gout, which the patient never had in the past. The adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with steroids. The clinical outcome of the event gout was recovering.  No follow-up attempts are needed. No further information is expected.
Patient had an anaphylactic reaction to the vaccine the day after it was given and went to the nearest ER.
p/vax pt presented w/a rash which was quite painful, involving the hands, arms, antecubital axilla & upper shoulder;cult of rash was taken but pt had been tx w/zovirax & result negative;dx shingles;
Hives, nausea (5+ days started 1/27/2022) and vomiting (3 times since 1/27/2022). As of 2/01/2022: Hives showing improvement. Nausea showing improvement. Vomiting Last time 1/31/2022.
fever; body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis in October 2019. Concomitant products included DIMETHYL FUMARATE (TECFIDERA) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PYREXIA (fever) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, PYREXIA (fever) and MYALGIA (body ache) had resolved. Not Provided
She received Tdap on 10/2/19 and developed significant arm pain same day that has been persistent.  Rash developed 2 days ago and it's spreading.  No fevers, doesn't feel ill.
7 syncopal episodes lasting less than 1 minute over 11 months (last one in 6/00). Episodes began with heat exhaustion during road march in late February or early March/2000. Second episode occurred in 4/00, again with 12 mile road march. Our pt had evaluations by cardiology, pulmonary, endocrine and psychology specialists and no etiology has been identified as a cause. Another soldier in his unit was discharged and had syncopal episodes as well.
Staff member reported that greater than 24 hours later she noted swelling to her injection site and then also started feeling fatigue, stomach cramps, joint pain, nausea, headache, chills and temperature of 101F. Today she reports fatigue, injection site swelling and redness and heat to site, cramping, nausea and chills.
Information has been received from a GlaxoSmithKline (manufacturer # A0710606A) concerning a 4-year-old male with a history of hives with OMNCEF and no other known allergies or drug reactions, who on 25-JAN-2008 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (the patient had at least one previous dose) (lot # 655103/0862F); Suspect therapy that day included a fist dose of varicella virus vaccine live (OKA/Merck) (MSD) (lot # 658287/1173U) and a second 0.5 ml dose of hepatitis A vaccine (inactive) (HAVRIX) administered at 12:00 in the left arm. There was no reaction on previous exposure to vaccines. In approximately January 2008, post vaccination, the patient experienced an anaphylactic reaction and a non-specific reaction. The patient was treated with 2 doses of EPINEPHRINE, BENADRYL, oxygen and prednisone. Once stabilized, the patient was sent to the emergency room for observation but was not admitted. He required no further treatment. The patient had no reaction to the first dose of hepatitis A vaccine (HAVRIX). In approximately January 2008, post vaccination, the patient recovered. The adverse events reported were considered to be life threatening and Other Medically Important Events by the reporter. The reporter was originally reported by a physician (allergist). No further information is available.
Pain bilateral legs - started 2 days after flu vaccine.  Had MIR-EMG-CBC-S.5. Pt. was told all tests within normal limits. I suggested Neuro consult-scheduled for 01/14/2005. Medical Record received on 1/20/2005 states pt experienced paresthesia, weakness and sensory neuropathy.
post peri-menopausal heavy vaginal bleeding; This is a spontaneous report from a contactable consumer or other non-HCP. A 54-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on 26Feb2021 as DOSE 1, SINGLE (at the age of: 54-year-old) for covid-19 immunisation. Medical history included allergies in sulfa antibiotics, pennecillin, strawberries. No other vaccine was administered in four weeks. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. The patient's concomitant medications were not reported. On 06Mar2021 the patient experienced post peri-menopausal heavy vaginal bleeding. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient started feeling bad that evening  which was a Wednesday and throughout the weekend.  On Monday, December 2, 2019, the patient woke up with tongue swollen and blistered and blisters also on the inside of her mouth.  Had a fever on Tuesday, December 3, 2019 of 100 F.  Blisters are starting to heal but was still present as of December 12, 2019.
fever,  nausea vomiting diarrhea,   chills,  dizziness anxiety,  48 hours
30 minutes after receiving flu shot had nausea, bilateral leg pain, and light headedness.  Drove self to doctor.  Received phenergan and decadron IV.  S/S almost resolved immediately. Slept most of day and has been fine since.
COVID-19; COVID-19; Tested COVID positive on 10Aug. Started Paxlovid on 11Aug. Tested negative on 20Aug. Now tested COVID positive again on 25Aug; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 at 18:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LUPIN, start date: 01Jan2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Tested COVID positive on 10Aug. Started Paxlovid on 11Aug. Tested negative on 20Aug. Now tested COVID positive again on 25Aug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Aug2022) Positive, notes: Tested COVID positive on 10Aug; (20Aug2022) Negative, notes: Started Paxlovid on 11Aug. Tested negative on 20Aug; (25Aug2022) Positive, notes: Now tested COVID positive again on 25Aug. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The patient was treated with Paxlovid from 11Aug2022 to 15Aug2022 for the events. Clinical course: The patient has been isolating during this time.
Early morning hours 0100 of 12/19/2020, awoke with SOB/dizziness/polyuria/anxious/Heart palpitations/Tachycardia (no tx/went back to bed thought I was just anxious) Afternoon of 12/19/2020 Fatigue/dizziness/HA (Motrin) Early morning hours 0130 of12/22/2020 awoke with SOB/dizziness/Polyuria/anxious/Heart palpitations/Tachycardia 120-130/felt something wasn't (right) (went to Hospital ER, cardiac workup, multiple PVC's some couplets, tachycardia. Given a liter of fluids) Told it was a Large Catecholamine release related to my immune response to the vaccine, Told Heart was "irritated"
On 3/7/2021 the patient presented to the ED with chest pain lasting for about a week that was not relieved after taking nitroglycerin. The patient does have a history of coronary artery disease. The patient was admitted for NSTEMI.