chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse prescriber via company representative refers to a 73 year old female patient. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23, (route: intramuscular) for active immunization for the prevention of pneumococcal disease. On an unknown date, the patient experienced redness and swelling around the injection site for PNEUMOVAX 23. The patient sought medical attention for the events. The outcome of the events was reported as recovered on unknown dates. The causality of the events was unknown.
Information has been received from a registered nurse concerning a 10 year old female patient with no pertinent medical history or allergies who on 07-NOV-2000 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# not reported). On 08-NOV-2008 the patient was vaccinated with the second 0.5ml dose of VARIVAX (Merck) (lot# 660823/0421X). There was no concomitant medication. On 22-MAR-2010 the patient developed chickenpox. The patient presented with approximately 30 "dots" on her abdomen, arm and left upper thigh along with some fever. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient's chickenpox had not recovered. Follow up information has been received from the Registered Nurse who reported that the patient was re-examined last week (approximately on 15-APR-2010) and was recovering. All of her blisters were scabbed over most and most were gone. Additional information has been requested.
Allergic reaction on arm very painful and itchy. Had to take steroid pills for 6 days and use steroid cream as well. Has left me with a bruise.
Patient describes chest tightness. No pain, shortness of breath, palpitation, dizziness. Just tightness.
veins satrted feeling different(veins satrted pulsating in arm); This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISORDER (veins satrted feeling different(veins satrted pulsating in arm)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis (No recent change in status of chronic condition) since 2010 and Drug allergy. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), CROMOGLICATE SODIUM (NASALCROM) for Allergy NOS, CARMELLOSE SODIUM, GLYCEROL (REFRESH OPTIVE) for Dry eyes.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VEIN DISORDER (veins satrted feeling different(veins satrted pulsating in arm)). At the time of the report, VEIN DISORDER (veins satrted feeling different(veins satrted pulsating in arm)) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Multi Vitamin for energy. On 30-Aug-2021, patient got a steroid shot and on 01-Sep-2021, patient got B12 shot.   This case was linked to MOD-2021-301573 (Patient Link).
Pt received 5 yr old immunizations on 9/21. Returned to office on 9/24 with complaints of (L) arm red and swollen, painful, no change with Benadryl, warm and spreading. No fever. Pt treated for cellulitis with Cephalexin 250/5 - 2 tsp PO BID x 10 d.
Pain was immediate after administration of injection. Injection was administered to the back of the upper left arm by a an unsupervised nursing student. I have weakness, constant pain on upper left arm and left shoulder.   I have limited range of motion of left arm and shoulder. I have received physical therapy but no relief.  Currently on Gabapentin for possible nerve damage to injected arm.
After receiving injection pt. walked out of room and started feeling dizzy and passed out on the floor.  Pt. eyes were open and pt. was alert.  Pt states felt very lightheaded.  Went into room and laid on the table s/p check.  Pt. remained on table x 30 min.  Discharged in stable condition.
Hives at injection site; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (Hives at injection site) and HEADACHE (Headache) in an adult female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (Hives at injection site) and HEADACHE (Headache). At the time of the report, INJECTION SITE URTICARIA (Hives at injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medication or treatment for the events was reported.   This case was linked to MOD-2021-027687 (E2B Linked Report).; Sender's Comments:  MOD-2021-027687:Same Reporter
Received vaccine at 10am 5/20/22, toes began itching at 3pm same day. Broke out in rash/hives/itchiness thereafter. She took Benadryl and by am on 5/21/22 all had subsided.
This spontaneous report received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
pt recv vax 6MAR98 & 14MAR98 pt devel chickenpox;
Employee/patient had explosive diarrhea and then vomiting 1 hour after Flu injection. Only the one event. No further diarrhea or vomiting. Employee/patient was tested for COVID at a precaution and was negative. She only had the one event.
Information has been received from a nurse concerning a female patient with no pertinent medical history and no known drug reactions/allergies who in 2005 was vaccinated with her first three doses of RECOMBIVAX HB (manufacturer unknown). There was no concomitant medication. On 21-SEP-2005 the patient was tested for Hepatitis B titers and showed no immunity. On 07-FEB-2006 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 650890/0144R). On 13-MAR-2006 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 651363/0336R). On 01-AUG-2006 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 652711/1213R). The patient was recently tested for Hepatitis B titers again and showed no immunity. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Severe abdominal pain, vomiting, nausea, fever, chills starting at 5am continuing through the day. IV fluids and zofran administered at 2pm
Ended up getting the second shot for vaccine 48 days late; A spontaneous report was received from a consumer concerning a 74 year old-male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported Inappropriate schedule of vaccine administered.  The patient's medical history was not provided.No relevant concomitant medications were reported.   On 20 Jan 2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch 032120A) on left arm for prophylaxis of COVID-19 infection.  On 09 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch unknown) on left arm for prophylaxis of COVID-19 infection.  The patient ended up getting the 2nd dose of vaccine 48 days after the first dose (Inappropriate schedule of vaccine administered).  No laboratory data was provided.Treatment information was not provided.  Action taken with mRNA-1273 in response to the events  was unknown.  The outcome of the event was considered as recovered at the time of the report.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
lightheadedness; not myself; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11Mar2021 at 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications were not reported. The patient felt fine on the day of the first vaccine dose. On 12Mar2021, he felt not himself, lightheadedness. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Five minutes after receiving flu shot client c/o throat tightness, pressure behind eyes, heavy chest and itching. Given antihistamine referred to MD.
A couple of hours after 1st shot, my left knee (which I've had 9 surgeries on, synvisc injection, and is arthritic) swelled up very large far 5 days straight and was unresponsive to wrapping,  , electrodes + elevation.
Runny nose/ nasal congestion 10/4/09 - 10/7/09.  Fever (to 103.7).  Stomachache. Cough. 10/9/09 No residual sequelae.
Per telephone note in patient's chart 10/19/2009: On 10/15/09 Pt developed fever 102, had chills, eyes red itchy late in the evening.  Pt went to ER where physicians came to conclusion pt had allergic reaction to Flu SHOT. All testing done in ER was negative, even nasal swab for flu.  PT had received shot same day at the facility. Pt calling to report this reaction. Pt is feeling fine today.
Pt developed nausea, vomitting morning after receiving vaccine. Daily symptoms of N/V x 7 days
An hour after receiving vaccine I started feeling numbness on my throat and on the left side of my throat.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 29-year-old) at 12:30 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 13:30, the patient experienced numbness on throat and left side of throat. No treatment was taken for any of the reported events. The clinical outcome of the event numbness throat was not recovering at the time of report.  No follow-up attempts possible. No further information expected.
5 hours after getting the 2nd dose, I felt like my sugar was dropping and felt shaky and lightheadedness. That evening I spiked a fever 102, body aches, joint pains which lasted about 12 hours and resolved. About 3 days later, my lymph  nodes in my left arm pit became swollen. I consulted with my doctor and he advised to wait and see. They lymph node continued to get bigger. Around the middle of July 2021, I did finally get an ultrasound. The results of the ultrasound was "suspicious" and I was ordered to get another ultrasound with mammogram. In August 2021, I did another ultrasound and mammogram.  The ultrasound showed the lymph nodes had become even larger and the mammogram was normal. The doctor now wants to do a biopsy which I did in Sept 2021 and I am waiting on the results of the biopsy.
Approximately 2 weeks after receiving the 2nd dose I started experiencing joint pain in my knees intermittently.  Over the next 2 - 3  weeks up unto and including today the pain has been increasing and I have been experiencing swelling in my joints as well.  The areas that I am experiencing the pain and swelling are knees, ankles, feet, and hands.
Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoulder pain; High BP of 294/224; High blood sugar of 750; Severe allergic reaction; Tingling in the right arm; Numbness; Heaviness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High BP of 294/224) and BLOOD GLUCOSE INCREASED (High blood sugar of 750) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High BP of 294/224) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (High blood sugar of 750) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), HEADACHE (Severe headache) and ARTHRALGIA (Right shoulder pain). On 28-Feb-2021, the patient experienced VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (High BP of 294/224), BLOOD GLUCOSE INCREASED (High blood sugar of 750), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), HEADACHE (Severe headache), ARTHRALGIA (Right shoulder pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 750 High. On 26-Feb-2021, Blood pressure measurement: 294/224 High. On 26-Feb-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No new information was updated from  follow up document.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment.
Pain and redness around injection site near deltoid muscle present along with redness farther from injection site running down arm.
Rec'd YF and TWINRIX 10/14/16. Started having hives (generalized) 10/20/16 with itching of skin. No other SX. Seen PCP 10/24/16. RX: Prednisone and ZYRTEC. Beginning to resolve.
Small red and hurting bump (swelling) of two to three inches below the injection site; Small red and hurting bump (swelling) of two to three inches below the injection site; Small red and hurting bump (swelling) of two to three inches below the injection site; A Spontaneous report was received from a consumer, concerning herself, a 66-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed small red and hurting bump (swelling) of two to three inches below the injection site.  The patient's medical history and concomitant medication were not reported.  On 11-Jan-2021 prior to the onset of the event, the patient received their first dose of mRNA-1273 (Lot number: not provided) via intramuscular route on the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, on Saturday, after the day she received the vaccine, she developed small red and hurting bump (swelling) of two to three inches below the injection site. Laboratory test was not provided. Treatment for the event included acetaminophen and ice pack.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome of event, small red and hurting bump (swelling) of two to three inches below the injection site was unknown at the time of this report.; Reporter'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.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 72-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 06-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804081 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Shortly after getting shingles vaccine (approx 4 yrs ago), I began experiencing rashes on my arms, torso, thighs and legs. Skin was itchy and felt like it was on fire.
Intermittent Arm and Hand Tingling, Numbness, Occasional shocking and minor loss of grip. Right hand more severe than left. Increasing frequency as time passes. Duration 10 minutes to several hours. I have not seeked medical help yet. Hoping this is a temporary issue.
Strong flu like sym,ptoms. aches and pains, fever, chills. Unable to get out of bed! Extremely sick for about six hours, then began to recover.
Shingrix only adjuvant used; Only adjuvant administration; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 03-OCT-2022 Reporter's comment: A health care professional reported that a female patient received only the adjuvant of Shingrix. The reporter was consented to follow up. Additional Supportive Information: The patient received only the adjuvant of Shingrix, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Havrix being given to a 2 month old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter reported that Havrix being given to a 2 month old patient, which led to inappropriate age at vaccine administration. No other details was given. The reporter consented to follow up.
4/5/21: Patient admitted to ED at 12:55 PM (last known well 1AM) with symptoms suggestive of stroke including: left side weakness, facial droop, slurred speech, dysphagia and fall x 3.  NIH stroke scale = 7. Diagnosis: acute right MCA infarct (embolic stroke). Patient was not a candidate for TPA. Risk Factors: diabetes mellitus, hyperlipidemia, hypertension, smoking and hypercoagulable state due to systemic inflammation from second COVID-19 vaccine. Throughout her stay, dysphagia and slurred speech improved but patient still had residual weakness and headache. While inpatient, patient received DVT prophylaxis with Lovenox, rectal aspirin 325 mg, normal saline fluids, sliding scale insulin, analgesics as needed, Requip, and antihypertensives as needed. She also received stroke education, diabetes education, smoking cessation counseling, PT, OT, and speech therapy. A loop recorder implant was placed on 4/7. The patient fell while in the hospital on 4/8. 4/9/21: Patient was discharged to Inpatient Rehab approx. 8:30 AM on the following medications: -- acetaminophen (TYLENOL) 325 MG tablet Take 2 (two) tablets (650 mg total) by mouth every 6 (six) hours as needed  --aspirin 81 mg chewable tablet Chew and Swallow 1 (one) tablet (81 mg total) daily . --atorvastatin (LIPITOR) 80 MG tablet Take 1 (one) tablet (80 mg total) by mouth nightly . --bisacodyL (DULCOLAX) 10 mg suppository Insert 1 (one) suppository (10 mg total) into the rectum daily as needed for constipation . --cyclobenzaprine (FLEXERIL) 10 MG tablet Take 1 (one) tablet (10 mg total) by mouth 3 (three) times a day as needed (Restless legs) . --enoxaparin (LOVENOX) 40 mg/0.4 mL Syrg Inject 0.4 mL (40 mg total) under the skin nightly for 20 days . --insulin glargine (LANTUS) 100 unit/mL injection Inject 5 (five) Units under the skin nightly . --insulin lispro (HumaLOG) 100 unit/mL injection Inject 0 (zero) Units to 15 (fifteen) Units under the skin at bedtime .  -- insulin lispro (HumaLOG) 100 unit/mL injection Inject 0 (zero) Units to 30 (thirty) Units under the skin 3 (three) times a day before meals . --nicotine (NICODERM CQ) 21 mg/24 hr Place 1 (one) patch on the skin daily . --sulfamethoxazole-trimethoprim (BACTRIM DS,SEPTRA DS) 800-160 mg per tablet Take 1 (one) tablet by mouth every 12 (twelve) hours for 5 days . --traMADoL (ULTRAM) 50 mg tablet Take 1 (one) tablet (50 mg total) by mouth every 8 (eight) hours as needed  --continue home doses of metformin, glipizide, bupropion, and omeprazole. --discontinue lisinopril.