chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red warm to the touch knot at the injection site; Red knot at the injection site,Itchy knot at the site of injection; itchiness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red warm to the touch knot at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Red knot at the injection site,Itchy knot at the site of injection) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history provided).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (red warm to the touch knot at the injection site) and VACCINATION SITE SWELLING (Red knot at the injection site,Itchy knot at the site of injection). At the time of the report, VACCINATION SITE WARMTH (red warm to the touch knot at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Red knot at the injection site,Itchy knot at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   Treatment using acetaminophen was reported
Chills/skin sensitivity 5/18/21 11:00pm-5/19/21 8:30pm Fever & joint pain (100-102) 5/19/21 8:00am-5/19/21 8:30pm
TINGLING AROUND LIPS, MONITORED FOR ADDITIONAL 15 MINS. (TOTAL OF 30MINS), PATIENT STATES TINGLING RESOLVED. REPORTED HEADACHE BUT STATES SHE HAD IT ALL DAY.
This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscles and joints hurt), ARTHRALGIA (Muscles and joints hurt) and FATIGUE (Exhausted and went to bed early) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 036A21A) for COVID-19 vaccination. Concurrent medical conditions included Diverticulitis. Concomitant products included CLINDAMYCIN for Dental treatment NOS, METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Diverticulitis, FAMOTIDINE, LORAZEPAM and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (Muscles and joints hurt), ARTHRALGIA (Muscles and joints hurt) and FATIGUE (Exhausted and went to bed early). At the time of the report, MYALGIA (Muscles and joints hurt), ARTHRALGIA (Muscles and joints hurt) and FATIGUE (Exhausted and went to bed early) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Heart rate: (Inconclusive) fast heart rate. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information not provided. This case was linked to MOD-2021-041007 (Patient Link).
Information has been received from a consumer concerning her 3 year old male grandson who "had a bad reaction to amoxicillin" and on an unspecified date was vaccinated with a dose of VARIVAX (manufacturer unspecified). It was reported that the patient "had a reaction" to the VARIVAX (manufacturer unspecified). The patient sought unspecified medical attention. At the time of the report the patient's outcome was not specified. No further information is available.
The pt developed fever up to 103 deg. F on 05/04/2002 for two days then erythemotous papule rash spreading to extremities.
Fever over 103 starting at 21:00 4/1. Extreme abdominal pain that made it had to move lasting almost 48hrs.
Inflammation to hand; Stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and INFLAMMATION (Inflammation to hand) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included METHOTREXATE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). On 01-Apr-2021, the patient experienced INFLAMMATION (Inflammation to hand). On 05-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck) had resolved. At the time of the report, INFLAMMATION (Inflammation to hand) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
chest pain after first dose; COVID arm; COVID arm after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain after first dose), VACCINATION SITE REACTION (COVID arm) and MYALGIA (COVID arm after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain after first dose), VACCINATION SITE REACTION (COVID arm) and MYALGIA (COVID arm after first dose). At the time of the report, CHEST PAIN (chest pain after first dose), VACCINATION SITE REACTION (COVID arm) and MYALGIA (COVID arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment drug was reported.  Company comment: Very limited information regarding this event has been provided at this time.  Based on the current case data, this case has been classified as invalid (no identifiable patient data).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Based on the current case data, this case has been classified as invalid (no identifiable patient data).
Warm rash at injection site; Raised rash at injection site; Red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm rash at injection site), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Red rash at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm rash at injection site), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Red rash at injection site). At the time of the report, VACCINATION SITE WARMTH (Warm rash at injection site), VACCINATION SITE RASH (Raised rash at injection site) and VACCINATION SITE ERYTHEMA (Red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Medication for diabetes, Thyroid medication, Antibiotic for bladder infection (over a month since the patient has started). Treatment information was not provided.
Began with hives on hands and neck area 3 days after covid vaccine,  I took benadryl before bed and woke the next morning to hives spreading to entire body. I took another dose of benadryl mid day. By evening I was in anaphylaxis with swollen lips and itchy gums. Went to the ER and received ephnephrine, intravenous benadryl, pepcid and prednisone. Was monitored for 3 hours, swelling was gone and symptoms had subsided. Went home. Next morning  symptoms were less but feet were tender to walk on and hands and feet were itchy. Picked up prescrription prednisone and loratadine and took both that morning. By evening afternoon was very itchy and hives on back, legs, arms and neck took benadryl that evening which helped but currently itchy red hives on arms, hands, neck, legs and feet - all over body. A new symptom is very swollen lymph nodes in neck.
TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.
Had Td next day lt arm red & swollen @ sight of inject; Monday lump size of golf ball under arm pit; glands swollen; seen in ER; Wed still tender & running t103-104; Thursday feeling better-still has lump; 11MAY92 recovered;
16 hrs after administration, very nauseated, passed out in bathroom.  Awoke with lump on head, broken tooth, hematoma on cut lip, chin, bruises on neck, chin, face, breast. Arm was red, swollen.  Lasted about a week.  Dentist had to repair tooth.
URTICARIA. ITCH A LOT GOING ON AROUND THE BODY TO DIFFERENT AREAS AND RED SKIN.
Per telephone call from mother, pt. had swelling, redness,warmth to touch and pain from site of injection to 6 inches below site of injection in a 2 inch band nearly around the arm.  Initially patient was pale and diaphoretic and this lasted about 4 hours. Per review of immunization record, most recent Td was 9/8/03.
A lot of itchy bumps to left arm especially in the anti-cubital areas; A lot of itchy bumps to left arm especially in the anti-cubital areas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 18:00 (Lot number: ff2589) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gluten intolerance" (unspecified if ongoing). Concomitant medication(s) included: METAMUCIL FIBRECAPS. The following information was reported: PRURITUS (non-serious), SKIN MASS (non-serious) all with onset 16Nov2021 12:00, outcome "not recovered" and all described as "A lot of itchy bumps to left arm especially in the anti-cubital areas". Therapeutic measures were not taken as a result of pruritus, skin mass. No follow-up attempts are possible. No further information is expected.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
the other 15 people I know including my mom, my sister, my daughter, and a bunch of friends call to report they can stick a magnet to their arm too?; lymph node swelling; This is a spontaneous report from a contactable consumer (Patient).   An unspecified years-old and gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route on an unspecified date, as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient stated that the other 15 people I know including my mom, my sister, my daughter, and a bunch of friends call to report they can stick a magnet to their arm too. Another family member got the Moderna vaccine, and they can do the same thing. So it is not only your vaccine, but Moderna as well. She is not one of those wackos that thinks it's a microchip, but she is sure others will. On an unspecified date, the patient experienced lymph node swelling. All the events were non-serious. The outcome of all the event were unknown.   No follow-up attempts are needed; Information on the lot/batch number has been requested.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer survivor" (unspecified if ongoing), notes: Cancer survivor. 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 "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown whether the patient was taking any other medication in 2 weeks. It was unknown if the patient had allergies. It was unknown whether the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
CHILD STARTED C/O BOTTOM OF FEET ITCHING WITHIN 5 MINUTES OF RECEIVING INJECTIONS. WITHIN 15 MINUTES RED RASH NOTED ON FACE, TRUNK, ARMS AND CHILD WAS C/O ITCHING ALL OVER. WHELPS NOTED ON ARMS. BENADRYL 6.25MG IM GIVEN. AFTER 30 MINUTES RASH WAS RESOLVING. CHILD NO LONGER C/O ITCHING. ALL WHELPS GONE EXCEPT 1 ON THE LEFT FOREARM.
Local urticaria left upper arm, 5 minutes after injection erythema with central roused linear urticaria below injection site. Oral Benadryl given. Observed x 40 minutes. No progression. No other symptoms.
Horrible rash that continued to worsen. Finally took to ER and they said he was having an allergic reaction to something in the MMR vaccine. It continues to worsen even after Prednisone. No itch cream helps and he is bleeding from constant scratching.
Information has been received from a certified medical assistant (C.M.A.) concerning a female patient between the ages of 11 to 15 years old who on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil, (Lot # not reported). Subsequently the patient experienced pain at the injection site lasting for about a week. This is one of several reports from the same source. Additional information has been requested
PHYSICIAN CALLED THE PHARMACY ON 3.24.2021 AND STATED THAT THE PATIENT HAD CELLULITIS WITH SYMPTOMS BEGINNING ON MONDAY 3.22.2021
This spontaneous report was received from the patient's mother, concerning a 10 month-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates (reported as the 2 and 4 months of the patient's age), the patient was intramuscularly vaccinated with PEDVAXHIB injection (dose, frequency, lot # and expiration date were not reported) and an unspecified date (reported as the 10 months of the patient's age), the patient received a booster intramuscular injection of PEDVAXHIB (dose, frequency, lot # and expiration date were not reported), all for prophylaxis. No adverse effects were reported. Additional information is not expected, as no consent to contact the reporter was granted.
Patient is a 16 month old male had immunizations in both legs a few days ago. The right thigh has cellulitis and induration. I prescribed antibiotics and a cream.
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Arm hurt / sore arm), FRUSTRATION TOLERANCE DECREASED (Frustrated) and IMPAIRED WORK ABILITY (can't function) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003CZ1A or 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and HYDROCHLOROTHIAZIDE for Blood pressure, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN), SERTRALINE and CLONAZEPAM (KLONOPIN) for Depression, METFORMIN for Diabetes, SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (Arm hurt / sore arm), FRUSTRATION TOLERANCE DECREASED (Frustrated) and IMPAIRED WORK ABILITY (can't function). On 28-May-2021, the patient experienced FATIGUE (I have extreme fatigue for 3 weeks). At the time of the report, SOMNOLENCE (Sleeping day and night ,I have been sleeping more , have been sleeping both afternoon and night), FEELING COLD (Feeling cold) and FRUSTRATION TOLERANCE DECREASED (Frustrated) outcome was unknown and PAIN IN EXTREMITY (Arm hurt / sore arm), IMPAIRED WORK ABILITY (can't function) and FATIGUE (I have extreme fatigue for 3 weeks) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-201744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Concomitant medication added. Event extreme fatigued added
Patient reported to the pharmacy 11/2/23 that she believes the vaccine was given too high on her left arm. She noticed right away as she could feel the vaccine going into her arm at the time of vaccination. She reported the first couple days immediately following vaccination were very painful and she described the pain as feeling like a "hammer hit" to her shoulder. She said after the first couple days, the pain decreased a little to where it feels like a "half hammer hit", but the pain is still there. She has tried ice, ibuprofen, and tylenol with little relief. She has not seen a doctor for this yet, but she has an appointment with her primary doctor in mid-November and will discuss with the them if the pain does not improve.
Patient received PCV-13 vaccine on 06/02/16. State that she started with fever the same day and continued for 48 hrs. Also developed rash on both arms (5x7 right arm) and swollen hands.
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot# K008213 with expiration date 17-DEC-2016, lot# K009105 with expiration date 21-JAN-2016, lot# K008931 with expiration date 04-MAR-2017 (reported as 2107) and lot# K006191 with expiration date 09-FEB-2017 (dose and route of vaccination were not reported). No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
Extreme vaginal bleeding, bright red. My cycle had ended the day before. Bleeding enough to need largest size tampon every hour for 4 hours then every other hour until morning. Bleeding has not stopped but has lessoned. No pain or cramping. Regular cycle had started on 5/22.  Severe headache started within an hour of the shot and lasted 2 days.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date the patients were vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). No co-suspect or concomitant medications were reported. On an unknown date, after receiving the zoster vaccine live, the patients subsequently had contracted "Shingles". It was not specified if the patients sought any medical attention. The outcome of shingles was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
It started as itching in the right arm, then the left arm and back and then the whole body. The patient also reported pain at the site of the vaccines administration.
Had vaccine at 1:05 pm on 7/1/19 & was tender/sore with some swelling that night.   Next day on 7/2/19 had same symptoms as on 7/1/19. On 7/3/19 woke up at 6:50 am with 6 mild red hives starting at injecton site on upper left arm extending down approximately 2 inches.  It turned into red blotches after a few hours, was tender/sore with a swollen hard lump which my PA-C thought might be cellulitis so she had me go for an office visit.  It was not cellulitis, but  a side effect reaction.
Lymphadenitis on the left axilla 4-days, Rash on chest on upper arms 11:00AM  2-3hrs
No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 24-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date: 20-MAY-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055: