chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain; blood pressure was elevated; soreness; headaches on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain), HYPERTENSION (blood pressure was elevated), VACCINATION SITE PAIN (soreness) and HEADACHE (headaches on and off) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain), HYPERTENSION (blood pressure was elevated), VACCINATION SITE PAIN (soreness) and HEADACHE (headaches on and off). At the time of the report, PAIN IN EXTREMITY (pain), HYPERTENSION (blood pressure was elevated), VACCINATION SITE PAIN (soreness) and HEADACHE (headaches on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 127 elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-068610 (E2B Linked Report).; Sender's Comments:  MOD-2021-068610:First dose of vaccine case.
tingling at tip of her tongue; tingling at fingertips - both hands; Hot spots inside of elbow - both elbows; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (tingling at tip of her tongue), PARAESTHESIA (tingling at fingertips - both hands) and FEELING HOT (Hot spots inside of elbow - both elbows) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling at tip of her tongue), PARAESTHESIA (tingling at fingertips - both hands) and FEELING HOT (Hot spots inside of elbow - both elbows). At the time of the report, PARAESTHESIA ORAL (tingling at tip of her tongue), PARAESTHESIA (tingling at fingertips - both hands) and FEELING HOT (Hot spots inside of elbow - both elbows) outcome was unknown. Not Provided      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 relevant concomitant medication was reported. No treatment details  were provided.
Patient reports sensation of heart racing as well as feeling clammy. He states that he is not light headed and does report history of anxiety, stating that he takes Xanax as needed. Symptoms come in waves and are short lasting. Patient was given juice and crackers and was monitored in medical observation. Reports feeling a "twinge" in vaccinated arm. BP 122/74
Swollen lymph nodes under her arm pit; Discomfort under her arm; Discomfort under her arm pit; Chest discomfort; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 ( (PFIZER BIONTECH COVID19 VACCINE), via an unspecified route of administration in arm left on 29Mar2021 at age of 73-year-old as dose 2, single for COVID-19 immunization.  The patient's medical history was not reported. The patient's concomitant medication included antibiotics, sulfamethoxazole, trmethoprim (reported as SULFA TMP or BACTRIM) for antibiotic therapy. On an unspecified date, the patient previously received bnt162b2 as dose 1, single for COVID-19 immunization.  After her first shot, the patient had nothing. On 30Mar2021, the patient experienced swollen lymph nodes under her armpit, discomfort under her arm, discomfort under her arm pit and chest discomfort. Around 3:00 or 4:00 pm on 30Mar2021, the patient had discomfort under her arm and arm pit. The patient suspected lymph nodes under her armpit that were bothering on 30Mar2021. It was not very comfortable. The patient didn't feel it on 29Mar2021.That was the reaction that the patient had swollen lymph nodes. Her shot was in a straight line to her arm pit. The patient had an appointment with her primary on Monday. The patient wanted to know how long this would last and whether had any information. Swollen lymph nodes which generally resolved within 10 days was likely to have resulted from a robust vaccine-elicited immune response. The patient stated that this arm pit thing bothered her, and she did not recall what they said at the site where she got the shot and she did not know if she should keep a watch on it and then if it lasted a few days whether call her doctor or not. The patient stated it started under her arm and it was spreading towards her chest, it was not comfortable at all and she did not know how long this might last. The patient stated that she had done none, it just started happening an hour ago, and she didn't know if she should do anything. She stated whether she were to apply cold to armpit area since it was in direct line with vaccine site so cold could make the vaccine congeal, and she used heat it could make vaccine dissipate, so she was not sure about doing this. She stated it was on the same side where she got the vaccine, and if she presses where she got the vaccine it was a direct line to under her armpit. The outcome of these events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother described papular erythemic rash localized on upper torso and arms; resolving w/MOTRIN and EUCERIN bath.
Rheumatologic, Neurologic, Autoimmune symptoms. Chronic dizziness, headaches, confusion, disorientation, nausea, fatigue, thyroiditis, edema.
Reporter states that children (approx 4) are crying more when vaxed from a particular vial-lot# M635FN; crying occurred only during the vax; did not hear any more from parents;
Chicken Pox like rash  i.e. elbow bend, forearm, elbow, hip, thigh, stomach under breast all on the left side of the body.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing); "known allergies: Dairy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient did not receive other medication in 2 weeks. Patient received Paxlovid (anti-viral) from 14Jun2022 to 18Jun2022 for COVID 19 treatment. Rebound of Covid 19 after 5 days of taking Paxlovid.
Shaking chills, fever, severe headache, joint pain and body aches limited my ability to work   Started 12 hours after second dose of covid vaccine.  No reaction to first dose.
Got Shingles and congestion around his heart, swelling in the joints and eye irritation
This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in January 2016, the patients were vaccinated with improperly stored dose (temperature: 49 F, time frame: 1 hour) of ROTATEQ (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. Additional information has been requested.
Severe,  persistent,  uncontrolled asthma, started 4/19/21 and has not improved
Fever, chills, muscle aches for 12 hours  swelling at injection site for 3 days
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 22 months old male patient who received 0.5 ml vaccine FLUZONE QUADRIVALENT lot U6260BA, expiry date:30-Jun-2019 via intramuscular route in the left thigh on 29-Oct-2018 at 04:45. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose. It was reported that a 22-month old male patient was given FLUZONE QIV 0.5 ml, not 2 of the 0.25 ml in error. No bad effect, symptoms or adverse event reported and no known treatment. 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 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. Documents held by sender: none.
Tested positive to Covid 19; Tested positive to Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Jun2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications within 2 weeks of vaccination. 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. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2021, outcome recovering. The event tested positive to covid 19 and tested positive to covid 19 was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (20Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. It was reported that the patient tested positive to Covid-19 with headache, sore throat, chills, muscle aches, and cough. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Hives; Belching and gas; Gas; Woke up with no appetite; Chills; Fatigue; Felt like was going to black out; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), URTICARIA (Hives), ERUCTATION (Belching and gas) and FLATULENCE (Gas) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN D3, BIOTIN and ACETYLSALICYLIC ACID (ST. JOSEPH ASPIRIN ADULT CHEWABLE) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), ERUCTATION (Belching and gas), FLATULENCE (Gas), DECREASED APPETITE (Woke up with no appetite), CHILLS (Chills) and FATIGUE (Fatigue). On 28-Feb-2021, the patient experienced URTICARIA (Hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 for Hives, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (Felt like was going to black out), DIZZINESS (Felt dizzy), URTICARIA (Hives), ERUCTATION (Belching and gas), FLATULENCE (Gas), DECREASED APPETITE (Woke up with no appetite), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.            This case was linked to MOD-2021-029450 (Patient Link).
REDNESS, PAIN, AND HEAT AROUND INJECTION SITE ON LEFT ARM 1-3 DAYS LATER
From initial information received on 10/22/2004 from a health care professional regarding and adverse event occurring in the U.S. A., it was reported that a six month old female patient received her 1st dose of Fluzone SV '2004-2005 USP, lot number U1454AA, administered IM in the RT on 10/16/2004. Two days later on 10/18/2004, the patient developed a pimple like rash on her upper chest, back and shoulders. RAST testing to egg white gelatin was not ordered. Reportedly the patient recovered from these events.
Pruritic, erythematous, slightly tender, ovoid lesion on left upper arm ("Moderna arm").  Rx: Topical fluocinonide cream, 0.05%, BID for 4 days Lesion resolved completely.
massive stroke; This spontaneous report was received from a patient of unknown gender and age and referred to herself/himself.  The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date in 2018, the patient was ordered to get a dose of zoster vaccine live (ZOSTAVAX) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis, which was to qualify for life-saving surgery. And on an unknown date (reported as 10 days later), the patient had a massive stroke. The outcome of event was unknown. The action taken was not applicable.  The patient considered the event was undeniably caused by zoster vaccine live (ZOSTAVAX).  Upon internal review, the event stroke was considered to be medical significant event.  This is one of two cases sent by the same reporter.
Profound myalgias with high CPK. Weakness.  10/13/09 Medical records received.  Dates of Service 9/28/09 to 9/30/09.  Assessment:  Polymyositis. Patient presented with a 4 day history of profound body aches, chills, fever as high as 102-103, mild cough, muscle pain and weakness, fatigue, nausea and some shortness of breath.  The onset of symptoms was the night she received her influenza vaccine.  Started on prednisone are scheduled to return to clinic in two days.  Pt. diagnosed with polymyositis probably due to the influenza vaccine.  Upon return to clinic pt. was dramatically improved, pain was improved, she still had some fatigability with lots of effort, her cough was gone and she denied any additional symptomology.  Pt. to follow up with any additional concerns.
About 9 days I woke up with body aches, fatigue, nausea, and phlegmy cough. I took a COVID-19 test at home and it was negative. I tested several test after and it was still negative. I called doctor and she didn't know what it was and she prescribed me an antibiotic to see if it goes away. It is the third day of the antibiotic and I am starting to feel a little. I still have the cough.
Fever Sweats, Body Aches, Headaches. Lump in left Breast.
Child received shots 6/19/03, 6/20/03 about 5pm mom woke from nap-child blue-nonresponsive-called 911- went to ER, transferred to another hospital, admitted for 3days, discharge diagnosis- seizer disorder: apnea resolved; Braecardia resolved, & Bilateral, acute otitis media.
Rash Rt arm 9-27-08 Redness and swollen, few days later Rash Rt. arm
2 days after 2nd vaccination, onset of arm, hand numbness and painful rash, bumps in all extremities and under breasts. Also headache and nose bleeding. Then about 1 week out with some improvement of above, onset of photophobia and bilateral eye pain. 2/20/21 ER evaluation also with ophthalmologist found anterior bilateral uveitis Suspect SIRS/hypersensitivity like reaction from vaccine leading to above and placed in observation overnight at hospital. Improved with pred forte1% q 1hr and cyclogyl 1% BID. Testing for other systemic disease sent.  Headache and swelling responded to toradol X1. She is recovered and will be followed by EYE clinic as outpt
Fever  100.4,  3/26/21 9am, 6pm, 10pm   Severe headache (7 of 10 on pain scale) 3/26/21 All day   Nausea  3/26/21 9pm   Body aches  3/26/21 All day
This spontaneous report as received from a registered nurse referred to a 15 years old female patient, with no known drug reactions/allergies and no other pertinent medical history. The patient was vaccinated with dose 1, of 0.5 ml GARDASIL (lot # 0022AC) on 06-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-JUL-2012 the patient experienced feeling hot and itching, 24 hours after onset of therapy. 48 hours later the patient experienced lips swelled up and and still itching. 72 hours later the patient still had hives. The patient contacted physician for medical attention. The patient was given BENADRYL by her mother, as a treatment for the AE. The outcome of itching, hives, lips swelled up and feeling hot was reported as recovering/resolving. The relatedness for feeling hot, hives, lips swelled up and itching was unknown for GARDASIL. Additional information has been requested.
hands and the bottom feel tingling; Lips looks like she had Botox; hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching; Vaccination site hives; hands and the bottom feel itchy; chills; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN IN EXTREMITY (Sore Arm), URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives) and PRURITUS (hands and the bottom feel itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included ATORVASTATIN, PAROXETINE and CENTRUM WOMEN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced CHILLS (chills) and PAIN IN EXTREMITY (Sore Arm). On 05-Feb-2021, the patient experienced URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives), PRURITUS (hands and the bottom feel itchy) and LIP PAIN (Lips looks like she had Botox). On 07-Feb-2021, the patient experienced PARAESTHESIA (hands and the bottom feel tingling). On 27-Jan-2021, CHILLS (chills) had resolved. On 07-Feb-2021, URTICARIA (hives on the back part of the waist/ hives in both cheeks of the butt, and was very itching), VACCINATION SITE URTICARIA (Vaccination site hives), PRURITUS (hands and the bottom feel itchy) and LIP PAIN (Lips looks like she had Botox) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PARAESTHESIA (hands and the bottom feel tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Tylenol, Steroids, and Benadryl.
c/o "nausea, felt warm and sick to stomach". after vaccination, not first flu shot.
Information has been received from a 67 year old female with cholesterol high, cardiac murmur and sulfonamide allergy and a history of Shingles in her 30's who on 29-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 658398/1087U). Concomitant therapy included atenolol, SYNTHROID, therapy unspecified (water pill), aspirin, calcium (unspecified) and ginkgo. On 19-DEC-2007 the patient experienced Shingles attack. The patient reported that she had history of Shingles since in her 30's and every time she's exposed to somebody with chickenpox or if she was on a stressful condition, she would always get Shingles attack. The patient reported that from the time she received ZOSTAVAX (Oka/Merck), she already had 5 Shingles attacks in 7 months. The patient's Shingles persisted. The patient sought medical attention. Follow up information was received from the physician. The patient reported rash that was never seen in the physician's office for it. It can not state that the patient actually has Shingles. Additional information is not expected.
PROGRESSIVE STIFF FROM DAY 0 TO PRESENT, SWOLLEN LYMPH NODES, JOINT PAIN, FATIGUE AND MALAISE.
Blurry vision, difficulty  with memory, nausea,  brain  fog, weakness right hand, weakness both legs, pis and needles sensation  toes, slight  headache, sore arm
CHILLS; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and chills. This report was non-serious.
Swollen red area on right ant. bicep area. Ice applied.  Vaccine given Tuesday (9-02)per Mom.
2/13/15 Diarrhea, fever, stools green and foul smelling per mother. Admitted to Hospital for fluids. CBC (WNL).
SEVERE HEADACHES; VERTIGO; SLURRING OF SPEECH; NUMBNESS IN FACE [RIGHT SIDE] AND RIGHT ARM; DIZZINESS; UNSTEADINESS.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's pertinent medical history was not provided. On 17-APR-2014 the patient was vaccinated with ZOSTAVAX. Approximately in April 2014 (reported as few days after) the patient developed shingles. The pharmacist reports that the patient went to the emergency room (date of visit to the emergency room and name of emergency room was unspecified) and was diagnosed with shingles. Shingles were treated with antiviral Valacyclovir (manufacturer unknown). The outcome of shingles was unknown. The causality was not reported. The patient sought medical attention. Additional information has been requested.
Minor sore arm, but with urgent diarrhea with cramps and bloating.  On 4/15/2022 started diphenoxylate-atrop 1/QID, Dicyclomine 20 mg 1/QID, Metronidazole 500mg 1/BID. Note that my husband got his booster from the same batch and he only had a sore arm. NO Fever.  It's still going on.
On 12/18/98, the pt experienced a rash and irritability. The rash was described as consisting of "irregular margins, some were almost like you took a pin and made circles - it was slightly raised, in some areas it was a small spot and in some areas there was a very large area that was covered". The rash covered the pt from the bottom of the feet to the head. No further information is available.