chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the injection site was warm to touch; I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval; I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval; tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the injection site was warm to touch), VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE ERYTHEMA (I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval) and VACCINATION SITE URTICARIA (I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included AMLODIPINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site). On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (the injection site was warm to touch), VACCINATION SITE ERYTHEMA (I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval) and VACCINATION SITE URTICARIA (I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval). At the time of the report, VACCINATION SITE WARMTH (the injection site was warm to touch), VACCINATION SITE PAIN (tenderness at the injection site), VACCINATION SITE ERYTHEMA (I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval) and VACCINATION SITE URTICARIA (I have a giant red spot like a welt about 4 inches by 5 inches kind of an oval) 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 treatment information was provided by the reporter.
Per client report, her left arm has been getting numb since was given the flu shot in December. States just went to ER last Friday night (Jan. 20, 2012). Denies ever having any redness, swelling or drainage. Doctor only gave pain medicine.
Child received vaccine then mom said he started slurring his words and said he was sleepy.  He fell to the floor and temporarily passed out.  He came to and was responsive but sluggish.  He rested on floor for about 20 minutes in mom's lap, dad gave him some juice.  Then he got up and could walk to a chair to sit another 15-20 minutes and was feeling better.  His skin was warm and he said his stomach was upset.  Dad got an appointment with pediatrician to be checked out.  Called dad 4 hours later and child was feeling fine.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The reporter stated that, he heard that a patient who was administered with ZOSTAVAX may have developed cellulitis (date unspecified). The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab test were performed. The outcome of cellulitis was unknown. The relatedness for cellulitis was unknown for ZOSTAVAX. Additional information is not expected.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
At 5 hours post vax, experienced feeling freezing cold, fatigue, mild headache, mild body aches, soreness at vaccine site left arm.  At 12 hours post vax, experienced feeling of ?skin on fire? (not so much fever, just skin), and excruciating pain throughout body, worse left arm, neck, joints (worse in arthritic hands and feet; hands felt like animal paws). This was incapacitating. I had extreme difficulty moving, and I live alone. It lasted another 5 hours before slight improvement began.
Severe pain in lower back down to feet, severe swelling, stiff neck, fever, pain in eyes, jaws, and teeth. Prescribed Prednisone by healthcare professional. Was diagnosed with Adult Still's Disease.
Fever up to 103, rigors, intense myalgias, lymphadenopathy/lymphadenitis, sharp pains in feet, injection site pain, headache, vomiting lasting for 3 days. Still (4 months later) getting lymph node sharp pains frequently
vision became cloudy; This is a spontaneous report from a contactable consumer, the patient. A 37-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. The  medical history of the patient included COVID-19 on an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient's vision became cloudy around 2-3 days after receiving the vaccine. It had occurred with both first and second doses and happened both times and it was still happening at the time of report, months after receiving these injections. It was not every day that the cloudy vision would occur. NO therapeutic measures was taken as a result of the event. The clinical outcome of the event vision became cloudy was not resolved at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
MD reported got about 2 drops of hep b vax under nail;MD washed hands & felt a cool sensation in throat;
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N019923, expiry date: 28-APR-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: US-009507513-1709USA007012: US-009507513-1709USA007011: US-009507513-1709USA007014.
Pt received a second Influenza vaccination within 1 wk of each other. Pt had received the vaccine on the prior Saturday 9/25/10.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; LITTLE ACHE-Y; LITTLE BIT OF A SORETHROAT; TIRED; This spontaneous report received from a patient concerned a 56 year old female of an unspecified ethnic origin. The patient's weight was 215 pounds, and height was 62 inches. The patient's past medical history included: heart attack, and transient ischaemic attack (TIA), and concurrent conditions included: non alcoholic, non smoker, and hypertension (HTN). The patient had no drug abuse or illicit usage. The patient experienced drug allergy when treated with acetylsalicylic acid (ASA) used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1437217 or 143A21A, expiry: unknown) dose was not reported, 1 total, administered on 07-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included statins and Plavix (clopidogrel bisulfate) for heart attack, and blood pressure medications for hypertension. On 07-APR-2021, the patient was tired, little ache-y and had a little bit of sore throat for about a week. On 08-SEP-2021, patient started feeling sick (tired, achy, sore throat)- covid-19 infection. On 12-SEP-2021, patient underwent a nasal swab test (COVID-19 virus test) which came positive and patient was clinically confirmed with COVID-19 diagnosis (suspected clinical vaccination failure). All of these symptoms had resolved but a little tiredness was persistent.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little ache-y, little bit of a sore throat and tired on APR-2021, was recovering from covid-19 infection- feeling sick (tired, achy, sore throat), and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Sender's Comments: V0:20211014275-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
No adverse effects reported; her daughter received one dose of MMR II intramuscular; This spontaneous report was received from a pharmacist, and refers to a female patient of unknown age, who was her daughter. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On an unspecified date in March 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscular route in the left deltoid (lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
it was rpt concerning a pt who was exposed to varicella & on 14/aug/98 pt devel a cold sensation in right eye. eye was flushed for 2 min & subsequently recovered. addl info requested
pt recvd vax; TC from mom stating pt was experiencing stiff neck;no oth sxs;advised to take pt's  T & contact pt's PMD;
Dyspnea accompanied by flushing onset 1 minute after administration of vaccine. Lasted 2-3 minutes and resolved without treatment.
Patient took one dose of oral typhoid and began to experience headaches and fever.  Two days later, when he took the second dose, he again had headaches and fever up to 101 degrees, with chills.  He vomited as well.
Severe Migraines,Dizziness,Blacked out vision, Fatigue, Body aches,Neck pain, Back pain, abdominal pain, Rash on scalp, hand and foot tingling/falling asleep. No menstrual cycle. Foggy thinking.  7/01/09 H&P dated 12/18/08 received with dx:  Fibromyalgia.  Possible reaction to Gardasil vaccine.  Pt reports after HPV#1 (0688F) on 6/16/08 pt had worsening intensity and frequency of migraine H/A. After HPV#2 (0072X) on 9/2/08 pt had worsening of migraines and now extreme fatigue, abdominal pain, lower pelvic pain, back pain-lower, hand and foot paresthesias, pain all over, sensation of heaviness, forgetfulness and disturbed sleep. TX with antidepressants. PE (+) for 16/18 tender points in neck, elbow, knees and back.
This case is part of 1 cluster case and is linked to case number 2013SA113810 (same reporter, events after FLUZONE ID intradermal), lot number: UT4726AA. The five female patients, ages 18 to 64, medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Lot number UT4726AA, intradermal and site of vaccination not reported), on 29 October 2013. On 29 October 2013, after receiving vaccine the patients experienced warmth, swelling, redness and tenderness at injection site. Corrective treatment was not reported. At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 02-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Painful swelling in right leg from knee to ankle.  Skin is warm to the touch and red.
Dizziness, weakness, nausea, difficulty walking, shaking, sweating, burning pain down left side of spine and into neck, dead feeling in left arm. happened at 3:30am when tried to get out of bed, last hour or so until went back to sleep, lightheaded the rest of the day, sudden vision disturbances and severe headaches few days later for 3 out of 4 days.  Had a similar episode in December of 2020.
Tsted positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tsted positive for covid) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Tsted positive for covid). At the time of the report, COVID-19 (Tsted positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.   Reporter did not allow further contact
On day 4 p/inject devel fever, nausea, diarrhea, felt awful;
12/04/2022 I found a lump on a right breast. After contacting my health care provider, I was diagnosed with breast cancer. I am going to start Chemotherapy and started a trail with Abemaciclib, and Letrozole.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Tested positive for COVID again after 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests; (2023) Negative, notes: 4 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 24Jan2023 to 28Jan2023, lot number GF6389, indication Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Pt. stated he was feeling "woozy" to RN, pt. appeared pale and and his eyes were closing.  Moments later pt. had syncopal episode, Pt. was sitting in chair and was held in place by RN.  Syncopal episode lasted about 30 seconds.  His legs were elevated on nearby chair, inital BP was 71/36. NC cannula with 2 liter 02 placed. Pt. slowly woke up but blood pressure dipped to 51/21, HR 48, at that time pt was assisted to the floor and his legs were raised above his heart.  3 minutes later BP was 90/50 HR 55, and pt. was completely awake.  3 minutes later BP 103/57 HR 67, 5 minutes still on the floor, but sitting up BP 119/73 HR 74, given juice, pt. talking, laughing, color returned to normal.  5 minutes later, pt. sitting up in chair, BP 109/73 HR 73, 98% RA. During entire event SPO2 did not drop below 98%, Observed for total of 45 minutes.
He also had fatigue with this shot; He has developed a Swollen lymph node in the axilla of the arm he received the vaccine of the size of a small key lime, specifically, 1 and a half inches long and 3/4 inch deep; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for covid 19 immunization; Bnt162b2 (Dose 2), for covid 19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "He also had fatigue with this shot"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021, outcome "not recovered", described as "He has developed a Swollen lymph node in the axilla of the arm he received the vaccine of the size of a small key lime, specifically, 1 and a half inches long and 3/4 inch deep". Additional information: Relevant Tests: None. Family Medical History Relevant to AE(s): No. Caller did not believe that the patient had prior Vaccinations (within 4 weeks). AE did not result in Emergency Room and Physician Office visit. Causality of swollen lymph nodes and fatigue: Yes, Clearly.  Follow-up attempts are completed. No further information is expected.
Day after vaccine, 4/4/21 I had severe headache. Unable to get out of bed. Took tylenol (1000mg)around 9 am, headache still severe. Then about noon took prescription migraine medication. Slept until 4 pm. Headache less severe until 8 p.m that I took again migraine prescribed medication and slept until 11 am on 4/5/21. Headache started decreasing and felt ok again to take Tylenol. Saturday 10 and Sunday 11 Severe headache again. Medication worked only late (about 5pm) on Sunday 11 when headache started decreasing and I was able to sleep the night. Wednesday 14th, left lower leg and uncle area swollen (never before I had a swollen leg or foot) and right leg 3 red spots near my uncle (they kind of look like a mosquito bite but a little bigger). Today the red spots look smaller but I have bruises on both of my legs lower and upper sections (I been working in the garden so I might have bumped into things perhaps) I thought I just report this symptoms so you can add data to your system.
She woke up with her other leg (right leg) hurting her and  complained walking on it.
1. Injection (right tricep) site red, swelling, itchy, increased over several days then subsided after a week (have pictures if needed). 2. Right side below waist - itchy and big hive-like eruptions; LEFT forearm - two itchy red swollen spots that either came to a head or were scratched to crust. 3. Sensitivity to heat and sweat - hives or rash like eruptions on right side of neck 9/6 - 9/9.  Relief found by applying Ammen's medicated powder. 4. On Tuesday, 9/2/14 woke up at 2am with a bad sore throat - took Zicam which I have taken in the past with no ill effects.  Became a 'cold' - taking Mucinex DM extra strength 12 hr and Sudafed 12 hr and advil.  Cold is finally resolving as of 9/9/14 and hives have not increased.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 18-MAY-2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. During 2016, the patient broke out in severe blistering lesions.  The patient was treated at a medical center for the vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Within five (5) minutes after receiving vaccine and still in waiting area started having a strong metallic taste in my mouth. Lasted for 24 hrs and my husband a little longer (still tastes it in the roof of his mouth).
This spontaneous report as received from a nurse,refers to a male patient who was 3 days from completing 12 months of age. On 06-NOV-2013 the patient was vaccinated with VAQTA, dose: 0.5 ml, route: intramuscular, lot and expiry date: unknown. The patient was inadvertently administered with VAQTA 3 days before his twelfth month birthday. No adverse effects were reported. Additional information has been requested.
2 days after vaccination, patient called complaining of muscle twitching in right arm which radiates to neck. Also complaints of redness at site and running a fever with sick stomach. Patient had called her insurance companies nurse help line and told her to see her doctor. Patient went to the doctor on 4/17/03 and was admitted with a severe reaction to vaccine and patient states she also had a kidney infection.