chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. I lost the sense of touch from my elbow up to my shoulder and down the left half of my back.  A month after the vaccine I have regained some feeling, but the skin on my left should still cant sense touch. 2.  12 hours after vaccination, I experienced severe kidney pain that lasted 72 hours.  I have had kidney stones and a kidney infection so I know that it was my kidneys that felt as though they were rupturing.  I couldn't sleep or sit still for three days.  I did not take any pain medication as I did not want to overwhelm kidneys.  After 72 hours the pain finally subsided.
Back started hurting; Clammy; Started getting nauseous; Rash has become much bigger, red, and itchy.; Rash has become much bigger, red, and itchy; She developed a rash at the injection site/rash is bigger; Rash got bigger and hot to the touch; Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), VACCINATION SITE WARMTH (Rash got bigger and hot to the touch), BACK PAIN (Back started hurting), COLD SWEAT (Clammy) and NAUSEA (Started getting nauseous) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included Armidex, METFORMIN, LISINOPRIL, LAMOTRIGINE (LAMICTAL), DULOXETINE HYDROCHLORIDE (CYMBALTA) and PROPRANOLOL for an unknown indication.   On 06-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger). On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Rash got bigger and hot to the touch). On 08-Feb-2021, the patient experienced VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), BACK PAIN (Back started hurting), COLD SWEAT (Clammy), NAUSEA (Started getting nauseous), VACCINATION SITE ERYTHEMA (Rash has become much bigger, red, and itchy.) and VACCINATION SITE PRURITUS (Rash has become much bigger, red, and itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE RASH (She developed a rash at the injection site/rash is bigger), VACCINATION SITE WARMTH (Rash got bigger and hot to the touch), BACK PAIN (Back started hurting), COLD SWEAT (Clammy), NAUSEA (Started getting nauseous), VACCINATION SITE ERYTHEMA (Rash has become much bigger, red, and itchy.), VACCINATION SITE PRURITUS (Rash has become much bigger, red, and itchy) and VACCINATION SITE SWELLING (Swelling at the injection site which has gotten bigger\ump at injection site is getting bigger) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Hospitalized (10.7.21- still admitted currently);  COVID-19 positive (11.4.21); Fully vaccinated  CHIEF COMPLAINT:  COVID  HISTORY OF PRESENT ILLNESS Patient is a 83 y.o. male who presents today with COVID. The patient has a PMHx significant for CAD, HTN and CKD stage lll. The patient started having symptoms of COVID on 11/1, which included extreme fatigue, cough and SOB. The patient tested positive on 11/4. The patient has been having cough and SOB with increased exertional dyspnea. Today a portable pulse ox was placed on the patient and he was 85% on room air so he was brought to the ED. The patient otherwise denies N/V/D/C and dysuria. Patient states his last vaccine was in Feb.   Upon arrival to the ED CXR pending. Na 136. K 4.5. Cr 2.20. GFR 29. Platelet 122. WBC 5.21. The patient is requiring 2L NC but otherwise remains hemodynamically stable. The patient is being admitted to the SHMG for further management and evaluation.    PLAN:  COVID Pneumonia Acute Hypoxic Respiratory Failure Symptom onset 11/1 + PCR 11/4. Vaccinated.  CXR pending Decadron x 10 days Unable to do remdesivir at this time with kidney function. Could consider if kidney function improves.  Trend labs Supportive care Progress Note / PLAN from 11.17.21: ASSESSMENT / PLAN: Acute respiratory failure COVID-19 pneumonia Vaccinated Symptom onset 11 1 Chest x-ray 11 14 showing left-sided infiltrate Continued on high-flow nasal cannula Lasix 40 mg daily Completed Rocephin and doxycycline Decadron switched to Solu-Medrol 60 IV 2 times a day 11/14 If no improvement with high-dose steroids would recommend CT scan without contrast to rule out fibrotic changes
STARTED FEELING WEAK AND WITH JOINT SORENESS IN BOTH ARMS GOT STOMACH FLU SYMPTOMS AND THEN FLU SYMPTOMS.
body aches; shaking; fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 11:30 (Lot number: EL3248) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO; CITRICAL [CALCIUM]. Vaccination history included: Bnt162b2 (Product=COVID 19, brand=Pfizer , Lot number = EL3247, Administration date=17Feb2021, Administration time= 11:30, Vaccine location= Left arm, Dose number=1), administration date: 17Feb2021, when the patient was 55 years old, for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 09Mar2021 23:00, outcome "not recovered", described as "body aches"; TREMOR (non-serious) with onset 09Mar2021 23:00, outcome "not recovered", described as "shaking"; FATIGUE (non-serious) with onset 09Mar2021 23:00, outcome "not recovered", described as "fatigued". Therapeutic measures were not taken as a result of pain, tremor, fatigue.  Additional information: Patient was not given any other vaccine in four weeks. No Covid prior vaccination. Not covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (I just fell over and slept a long time) and MALAISE (felt like if I touched something I would break in pieces) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M#17B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included ATORVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HYPERSOMNIA (I just fell over and slept a long time) and MALAISE (felt like if I touched something I would break in pieces). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at a dose of 1 dosage form as required and PARACETAMOL (8HR ARTHRITIS PAIN RELIEF) ongoing since an unknown date at a dose of 650 milligram as required. At the time of the report, HYPERSOMNIA (I just fell over and slept a long time) and MALAISE (felt like if I touched something I would break in pieces) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-100860 (Patient Link).
Information has been received from a physician concerning a 25 year old female patient, with no pertinent medical history, drug reactions or allergies who on 23-AUG-2010 was vaccinated intramuscularly with the first dose of GARDASIL (Lot # reported as 0031Z. This lot# is valid for cancidas I.V., 70 mg exp date 20-NOV-2012). Concomitant therapy included VALTREX. The physician reported that the patient broke out in itch, maculopapular rash over arm and upper trunk. Valacyclovir hydrochloride was discontinued but the patient reported that the rash was on her face and lower body over the next 24 hours. On 26-AUG-2010, patient was placed on hydrocortisone 2.5% cream and BENADRYL. On 27-AUG-2010, patient reported worsening of the rash and was placed on therapy with prednisone. At the time of the report, the patient had not recovered. Additional information has been requested.
testing positive for COVID after receiving vaccine; testing positive for COVID after receiving vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar event for 14 patients. This is 6th of 14th reports. An elderly patient (more than 65 years old) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for COVID after receiving vaccine on 21Jan2021. It was reported that 8 patients and 6 workers at a long term care facility were vaccinated on 13Jan2021 and reported testing positive for COVID on 21Jan2021. Since they were testing positive, physician wanted to administer bamlanirimab (Lily drug being administered under FDA EUA). The event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.,Linked Report(s) : US-PFIZER INC-2021063794 same reporter/drug/event, different patient
Initial report was received from a consumer on 15 April 2013. A 28-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, lot number C3864 (corresponding Sanofi Pasteur Inc. lot number U3957CA) on 24 November 2012. Following vaccination, the patient experienced diminished function of left arm, was unable to use her left arm and had no grip strength. The patient is left hand dominant and has not been able to use her left arm. She cannot drive and has lost her job. Outcome was not recovered. Documents held by sender: None.
nausea; headaches; Off Label use; Interchange of vaccine products; booster dose; 9d post PFE boost saw return of dizziness when upright.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Moderna (Dose Number: 2), administration date: Feb2021; Moderna (Dose Number: 1), administration date: Feb2021. The following information was reported: OFF LABEL USE (non-serious) with onset 05Nov2021, outcome "unknown", described as "Off Label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 05Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset Nov2021, outcome "unknown", described as "booster dose"; DIZZINESS (non-serious) with onset Nov2021, outcome "not recovered", described as "9d post PFE boost saw return of dizziness when upright."; NAUSEA (non-serious), outcome "unknown", described as "nausea"; HEADACHE (non-serious), outcome "unknown", described as "headaches". The event "9d post pfe boost saw return of dizziness when upright." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: facility type vaccine: Pharmacy or Drug Store. Note patient on blood thinners. Also, nausea, headaches, kaleidoscope vision. All were new symptoms. At some point after MDRN vaccine pt fell, struck head got MRI, no findings. Post Pfizer boost saw return of dizziness when upright. This was a return of symptoms after 8 weeks of normalcy. Contact person was pt daughter and a nurse and is willing to provide more details on the case.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Entire rt buttock rt hip area red & swollen; painful to touch & area very warm; Noticed 15AUG91 in AM; 16AUg91 hip area is red & warm to touch, pt is able to ambulate, no edema or drainage from area;
Experienced fatigue, headache, intense body aches, 103.5 fever, coughing if inhaling more than normal breath.
Felt tired; very itchy back; headache; skin felt numb on mid-upper left side of back; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01Apr2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included mastectomy (on the right breast) on 31Dec2015 and breast tumor benign in the left breast. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) , lisdexamfetamine mesilate (VYVANSE), vitamin b nos (MANUFACTURER UNKNOWN, vitamin d nos (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not 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 02Apr2021, the patient reported that she felt tired but fine, she woke up 3am with a very itchy back, upon scratching her skin felt numb on mid-upper left side of back and she had headache for balance of the day. Then perfectly fine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event felt tired, very itchy back, skin felt numb on mid-upper left side of back and headache was resolved on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10-ish minutes after injection, patient noted throat was itchy and lasted about 15-20 minutes and then went away. And then after started feeling flushed and feverish. No meds were taken. Felt better once patient was leaving for day around 4pm. Then next day bruise appeared on injection site. Bruise lasted 11 days. Nothing further since those symptoms.
Pain in shoulder, inability to move arm, X-rays, MRI Oct 25 - Dec 20, 2016 Prednisone, Ibuprofen, Cortisone shot. Limited mobility Oct 2016 - present.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 04-OCT-2013 was vaccinated with VARIVAX (Merck), (lot # J003540, expiry date 25-MAR-2015) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA007815, 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009874, 1312USA009875 (Same reporter link). Additional information has been requested.
Date: 3/23/2021  Problem: feeling "woozy" Notes: Patient started feeling "woozy" after vaccine administration. Patient noted with blank stare, pale, & sweaty. BP 95/68 P:60 R:18, O2: 97.1 T: 9.0 Patients legs elevated to elevated BP. Patient came to and is awake, alert, & oriented x3. Small sips of water offered. BP: 117/77 P:61 R: 18 O2: 9& T: 96.4 Blood glucose. 128mg/dl. Patient states that she had-breakfast. Patient states that she had- breakfast. Patient able to stand up without feeling dizzy. patient walked to observation with observation nurses. Client observed for a additional 30 mins. After the 30 mins she states feel fine. T 98.8 P 64 R18 BP 120/74 O2 97% RA. AAOx3. Client left facility via personal vehicle.
High fever (101-103.2F), cough, fatigue, chills, muscle aches, joint pain for 7 days post vaccination
Started to feel warmth/rash same day of vaccine. just waited to see if it would resolve. Has gotten worse, traveled down outer arm to elbow. No fever no pain, just feels sore and warm to touch. No weakness of arm or restriction in movement. Skin:  right upper outer arm with erythema, no induration, warmth to touch nontender from lower deltoid to just above lateral epicondylar area.
Suspected vaccination failure; shingles/Had the shots and had shingles. I believe I had a milder case with the shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 24-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the Shingrix shot but still got shingles. The patient believed that this was a milder case with the shots. Additional Supportive Information: The follow up would not possible, as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Itchy red welts on both arms, hands and rib cage; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that:  A 36-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: Eng205), via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:15 (36-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were reported as none. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. The patient had no other medications in two weeks. On 13Mar2021 19:00, the patient experienced itchy red welts on both arms, hands and rib cage. No treatment was received for the event. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Headache, Fever, fatigue, arm soreness Narrative:  Headache, fever 101.9, arm soreness, fatigue; took ibuprofen; feeling better.
23APR98 pt very sleepy, fever, redness & swelling rt deltoid;c/o severe joint pain-did not want to walk;mom took pt to family MD;24APR sx dec still w/redness & swelling rt deltoid;
Pt. came in for her 1st dose of Pfizer vaccine at 7:20 p.m. 5 to 10 minutes after receiving her vaccine, she experienced palpitations, and lightheadedness. VS, 133/86, O2 sat 97%, heart rate 85. Patient complained of slight chest pressure. Pt. was monitored for another 15 minutes at which time, her s/s subsided. VS taken again , was stable. BP136/82, O2 sat 98%, with no palpitations.  Patient D/C to home.
received a dose of the vaccine past expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine past expiration date) had resolved.        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 concomitant medications are provided. No treatment medications are provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2 NOS), on 14Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "recovered" (Mar2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Was testing negative at the end of the Paxlovid dosage period. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was treated with Paxlovid from 08Mar2023 to 12Mar2023 and was tested negative at the end of the dosage period. The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Drug ineffective depends on many factors including, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300119454 Same patient, same reporter, different product, different events;