chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left back is itching. It's not broken out/being itchy; ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (left back is itching. It's not broken out/being itchy) and PAIN IN EXTREMITY (ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017A22A, 002B21A and 011M20A) for COVID-19 prophylaxis.     The patient's past medical history included Back surgery (3 years ago). Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2022, the patient experienced PRURITUS (left back is itching. It's not broken out/being itchy) and PAIN IN EXTREMITY (ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away). The patient was treated with PARACETAMOL (TYLENOL) on 10-Jul-2022 at an unspecified dose and frequency. At the time of the report, PRURITUS (left back is itching. It's not broken out/being itchy) and PAIN IN EXTREMITY (ack or arm is not red, won't stop, gets painful sometimes for a little while and then it'll go away) outcome was unknown.            The patient also took unspecified blood pressure medication.  The itchiness was located on the same place where the patient had back surgery.   This case was linked to MOD-2022-606180, MOD-2022-606193, MOD-2022-606195 (Patient Link).
pt took dose of DPH 7AM a/vax & 10AM 21APR97 recv vax on MD advice;reacted w/in 1hr of vax hives, swollen & sore arm, severe itching lasted 11 days;took atarax & Zyrtec to help control itching;
PT F/U X 24HRS FROM ADMINISTRATION OF ANTHRAX VACCINE 02 JUL 03 WITH A C/O OF SWELLING AND REDNESS TO LEFT WRIST.  PT SURGERY HX OF LEFT WRIST F/X REPAIR 10 FEB 03.  PT GIVEN MEDROL DOSE PACK 03 JUL 03.  PT F/U CONTACT VIA PHONE WITH "NO PAIN, REDNESS AND DECREASED SWELLING" 07 JUL 03.
5 days of extreme malaise/fatigue. 2+ months of severe deltoid and shoulder pain with significantly limited mobility; primary mobility restrictions were with external rotation; felt similar to a rotator cuff tear.  Currently, pain is abating and mobility improving.
Within 10 minutes I had a headache, racing heart and my tongue felt weird-tingly and numb. Within a half hour my lips tongue and throat were swollen. After an hour neck glands  were sore and there were a few hives around injection site. Then I took Benadryl and the reaction didn't get any worse but continues into the next day. I have been  taking Benadryl every 4 hours.
Very red and sore arm, fever, chills, very soon after and all day yesterday. Some better today
incontinence; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: INCONTINENCE (non-serious), outcome "unknown", described as "incontinence".  Additional information: Patient got booster and had bad side effects including incontinence.  The lot number for bnt162b2 was not provided and will be requested during follow up.
symptom of diarrhea; tiredness; This spontaneous case was reported by a hospital and describes the occurrence of DIARRHOEA (symptom of diarrhea) and FATIGUE (tiredness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (symptom of diarrhea) and FATIGUE (tiredness). On 12-Mar-2021, DIARRHOEA (symptom of diarrhea) and FATIGUE (tiredness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073794, US-MODERNATX, INC.-MOD-2021-073794 (E2B Linked Report).; Sender's Comments:  MOD-2021-073794:2nd dose US-MODERNATX, INC.-MOD-2021-073794:linked case
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 010A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown.            It was reported that the patient had a SARS-COV-2 antibody level equal to 1252 U/ml on 19-Oct-2021 and 183.1 U/ml on 29-Nov-2021.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No concomitant medications were reported. No treatment information were reported.   This case was linked to MOD-2021-404540, MOD-2021-404528.
Patient presented to pharmacy with a 3 to 4 inch circular rash on her upper left arm not itchy started a week after her immunization on 8/7/19
Got sick to my stomach; real bad pain in gallbladder area had to go to ER after six hours of nonstop pain; BP was 205/118 normal is 140/73; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in the arm left on 05Feb2021 14:00 as dose 1, single (at the age of 70-years-old) for covid-19 immunization. The patient medical history was not reported. Concomitant medications included naproxen sodium (ALEVE) and paracetamol (TYLENOL). On 06Feb2021, the patient got sick to stomach and real bad pain in gallbladder area. The patient had to go to ER after six hours of nonstop pain. All test on gallbladder came back negative. Blood was good. BP was 205/118, normal was 140/73. The patient took shot for pain and after a few hours everything started back to normal. The patient was sent home and he was good now. After leaving ER, the patient had great concerns about getting second shot and if this was a reaction to the vaccine. The patient received pain nausea medication. The patient performed full blood work up and ultrasound for the events. The patient did receive any other vaccine in four weeks. The patient did not have a covid-19 prior to vaccination. The patient did not test for covid-19 post vaccination. The outcome of the events was recovered.   Follow-up attempts completed. No further information expected.
Swollen lymph node over left collarbone that is sensitive to the touch. First appeared 3/26, no change through today, 3/29
nosebleed; This spontaneous case was reported by a pharmacist and describes the occurrence of EPISTAXIS (nosebleed) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 1. On 31-Dec-2020, the patient experienced EPISTAXIS (nosebleed). On 03-Jan-2021, EPISTAXIS (nosebleed) had lasted for three days.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No adverse effects reported; the patient was inadvertently administered a dose of VARIVAX intramuscularly rather than subcutaneously; the patient was inadvertently administered a dose of VARIVAX intramuscularly rather than subcutaneously; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, drug reactions, concurrent conditions and concomitant medications were not reported.  On 08-MAY-2019, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX), intramuscularly rather than subcutaneously (strength, dose, anatomical location, lot #, and expiration date not reported) indicated for prophylaxis.        No adverse effects were reported.
Extreme Fatigue.  Shortness of breath.  Impotence. Headache.  Pale skin
other three vaccines were given and it felt like he hit her bone; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ANA", start date: Aug2022 (unspecified if ongoing); "left bundle branch block" (unspecified if ongoing), notes: left branch bundle block diagnosed 12 years ago.; "Heart" (unspecified if ongoing). Concomitant medication(s) included: RANOLAZINE oral taken for cardiac disorder; IMMUNETI. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "other three vaccines were given and it felt like he hit her bone".  Additional information: The patient had ANA stands for antinuclear antibodies. It meant her immune system was about gone. She was diagnosed the past summer in Aug. Concomitant medication included Ranolazine one tablet by mouth twice a day when she did not forget it. Product was in a pharmacy bottle and caller did have lot to provide. The patient had been on it for 4 years off and on. Immuneti had vitamin c, zinc, vitamin D3, elderberry. It was an advanced immune defense vitamin. It was reported that the other three vaccines were given at  town and it and it felt like he hit her bone. Caller did not have that much fat on her body  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201392160 Same patient, different drug/ AE.;US-PFIZER INC-202201392176 Same patient, different dose/ AE.;
"2 days post vaccination (7/29), pt presents c/o bodyache, headache and feeling low grade fever but did not check temp.  Pt also has left arm redness, swelling, and itchiness <9cm in diameter. Vitals: BP 137/90, HR 70, Temp 97.9, SpO2 98%. Pt given a prescription for diphenhydramine and hydroxyzine to be taken as needed QHS. F/u on 7/30 showed HTN BP 148/105, HR 61, RR 18, Temp 97.9, SpO2 100%. HTN possibly medication related or undiagnosed HTN (elevated BPs in the past) but otherwise no change. PMH: hypothyroidism, DM, Anemia, menorrhagia w/ regular cycle, Obesity, s/p Myomectomy, s/p appendectomy. Medications at time of vaccination:  ferrous sulfate 325mg tab Take 1 tab BID levothyroxine 250mcg PO Daily Other medications have been prescribed but do not have consistent refill hx/ >1mo overdue for refill: fluticasone nasal spray, loratadine, Ortho Tri-Cyclen. "
The day after the vaccine I had a headache, chills and fatigue for the whole day. The following day I felt normal. Five days after the vaccine I had a silent miscarriage  and I was diagnosed on 04/19/2021. The doctor identified 04/10/2021 as the day that the fetus was no longer viable. I was in my seventh week.  The Pathology returned identifying Chromosomal abnormality.  Due Date-11/21/2021 First Pregnancy
4 hours after injection: foggy head feeling, pain radiating down arm. 10 hours after injection: lack of appetite, intense muscle and joint pain, chills, fatigue, foggy head feeling. 48 hours after injection: no muscle or join pain, no chills or foggy head feeling, still tired and no appetite.
Patient is an 88-year-old female with past medical history significant for arrhythmia, CVA with resultant left hemiparesis, HFpEF, dyskinesia, HTN, atrial fibrillation s/p ICD/pacemaker on warfarin anticoagulation, and hypothyroidism who presented for altered mental status, lethargy, and fever. Hypoxic respiratory insufficiency secondary to COVID-19 viral infection: symptoms began approximately on 9/13/2021, tested positive on 9/15/2021. COVID-19 vaccination status: vaccinated against COVID-19 with the Janssen vaccine on 7/2/2021. Previously on 2L oxygen, weaned to RA evening of 9/18/2021. CXR appeared to have only low lung volumes on 9/15/2021. Remdesivir for 5 days (end date of 9/20/2021) as patient missed her evening dose on 9/18/2021 due to IV access issues Dexamethasone 6mg daily while hospitalized. Did not require at discharge as discharged off of oxygen. Experienced acute encephalopathy in setting of mild dementia: baseline is difficulty recalling answers to complicated historical questions & home meds, but typically oriented per son. This improved similar to baseline at discharge.
Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MOUTH ULCERATION (Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding). At the time of the report, MOUTH ULCERATION (Mouth sores (Ulcers)-area like circle and spots and spots were not bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Email address and address of reporter
Per clinic note of 12 Dec 2019: "presents to the clinic with concern for diarrhea, joint pain for  72 hrs.  Patient with history of Crohns, diagnosed several years ago due to sores in his mouth.  He has seen GI in past with colonoscopy and has been on budesonide in past and llialda. Is currently only on oral dexamethasone for mouth sores.  He reports last colonoscopy last year by civilian provider. He has been well controlled.  He does report he was in another country last week and then had flu immunization on [09 Dec 2019]. "
3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime.  3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime.  3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.  3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.
FELT SLEEPY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had unknown drug abuse and drug illicit use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced felt sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt sleepy was not reported. This report was non-serious.
Pt states he had red rash on 6/27/11, itchy initially then painful on 6/28/11. Came to clinic and dx'd w/shingles, received valacyclovir 1gm TID x 7 days w/triacinolone cream. Pt rec'd ZOSTAVAX on 6/15/11.
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional, concerns a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
*mast cell mediated respiratory anaphylactoid and asthmatic crisis: shortness of breath, airway constriction, watery eyes, dry heaving, mucus production, and nausea-duration approximately 4 hours critical and 3 days elevated *lymphodemia: swollen, burning, and painful lymph nodes in armpit of injection site and around face/neck-duration approximately 21 days *fever-duration approximately 3 days
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 65 years old female patient who experienced tendinopathy of the left shoulder and abnormality of labrum concerning four tearing minimal, acromioclavicular joint degenerative changes, while she received vaccine ADACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. No concomitant medication was reported. On 12-Feb-2018, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot LU5798AB, expiry date 15 Nov 2019 via unknown route in the left deltoid. On 26-Jun-2018, the patient developed a non-serious tendinopathy of the left shoulder (tendon disorder) 4 months 14 days following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. On 26-Jun-2018, the patient developed a non-serious abnormality of labrum concerning four tearing minimal, acromioclavicular joint degenerative changes (arthropathy) 4 months 14 days following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. On 12-Feb-2018, the patient developed a non-serious generalized tenderness at the injection site (vaccination site pain) same day following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. On 02 Feb 2018 and had tenderness at the injection site, patient called back 3 days later and told caller that there was a red spot where she received the ADACEL, patient saw caller on 26 Feb 2018 and there wasn't a red spot at the injection site. Patient had full range of motion and generalized tenderness at injection site. On 04 Apr 2018, the patient went to a Neurologist and had a Electromyograph (EMG) on her left upper arm and it was normal. Patient went back to the Neurologist with pain in her right upper arm on 20 Jun 2018, patient was still having pain in left upper arm. On 26 Jun 2018, patient went to an Orthopedic MD and had a left shoulder MRI, results showed tendinopathy of the left shoulder and abnormality of Labrum concerning four tearing minimal, Acromioclavicular joint degenerative changes. Other relevant tests included- On 04 Apr 2018 had a Electromyograph (EMG) on her left upper arm and it was normal. On 26 Jun 2018 had a Left shoulder MRI- results showed Tendinopathy of the left shoulder and abnormality of Labrum concerning four tearing minimal, Acromioclavicular joint degenerative changes. Final diagnosis was abnormality of labrum concerning four tearing minimal, acromioclavicular joint degenerative changes and tendinopathy of the left shoulder. The patient was treated with TYLENOL 4 x/day and ice left upper arm, TYLENOL and alternate with Ibuprofen and get lidocaine patches for injection site, Gabapentin 1 at bedtime and twice a day with ice. The patient outcome is reported as Unknown for generalized tenderness at the injection site, as Unknown for tendinopathy of the left shoulder and as Unknown for abnormality of labrum concerning four tearing minimal, acromioclavicular joint degenerative changes. List of documents held by sender- none.
fatigue - onset about 1230, I usually don't take naps but I took a 4 hour nap that day headache - onset about 1230, lasted the rest of the day and intermittently the next few days injection site pain x 3 days - moderate, pain would wake me in my sleep if I rolled onto affected side
fatigue, diarrhea, that lasted approximately 4 hours the day after the injection. Resolved on its own. Injection site soreness x 24 hours.