chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist regarding to a 63 years old female patient with depression and with no drug reactions or allergies. On 14-JAN-2013, the patient was vaccinated with a dose of 0.65 ml of ZOSTAVAX vial 19,400 pfu 10 vials of 1 (subcutaneous, lot number was not provided) (Product circular number 9989115). Other suspect therapies included AFLURIA 0.5 mL intramuscular on 14-JAN-2013. No concomitant medications were reported. On 15-JAN-2013, after the patient received ZOSTAVAX and AFLURIA in the same arm at the same time, the patient now developed fever and redness (no rash). The patient received TYLENOL as treatment for the adverse events. Laboratory test was not performed. The patient sought medical attention, contacted pharmacist. At the time of the report, the patient did not recover from the adverse events. Additional information has been requested.
temperature of 101.94 ºF; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 101.94 ºF) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temperature of 101.94 ºF). At the time of the report, PYREXIA (temperature of 101.94 ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.94 ºf (Inconclusive) 101.94 ºF. In 2021, Oxygen saturation: 92 (Inconclusive) 92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
all of a sudden it was getting hard around the injection site/hard under her skin, and it's  slowly progressing and getting worse/arm is hard, and it's getting larger; right arm started itching really bad/it was the injection site; injection site is hot to the touch; swelling/It's been consistently swelling; a little bit of discomfort under my arm; it might have been a little lymph node/now it's rearing its head again/worse this time; slight redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is hot to the touch), LIMB DISCOMFORT (a little bit of discomfort under my arm), VACCINATION SITE INDURATION (all of a sudden it was getting hard around the injection site/hard under her skin, and it's  slowly progressing and getting worse/arm is hard, and it's getting larger), VACCINATION SITE PRURITUS (right arm started itching really bad/it was the injection site) and LYMPHADENOPATHY (it might have been a little lymph node/now it's rearing its head again/worse this time) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (slight redness at the injection site). On 15-Aug-2021, the patient experienced LIMB DISCOMFORT (a little bit of discomfort under my arm) and LYMPHADENOPATHY (it might have been a little lymph node/now it's rearing its head again/worse this time). On 16-Aug-2021, the patient experienced VACCINATION SITE WARMTH (injection site is hot to the touch), VACCINATION SITE PRURITUS (right arm started itching really bad/it was the injection site) and VACCINATION SITE SWELLING (swelling/It's been consistently swelling). On an unknown date, the patient experienced VACCINATION SITE INDURATION (all of a sudden it was getting hard around the injection site/hard under her skin, and it's  slowly progressing and getting worse/arm is hard, and it's getting larger). On 17-Aug-2021, LIMB DISCOMFORT (a little bit of discomfort under my arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site is hot to the touch), VACCINATION SITE INDURATION (all of a sudden it was getting hard around the injection site/hard under her skin, and it's  slowly progressing and getting worse/arm is hard, and it's getting larger), VACCINATION SITE PRURITUS (right arm started itching really bad/it was the injection site), VACCINATION SITE SWELLING (swelling/It's been consistently swelling) and VACCINATION SITE ERYTHEMA (slight redness at the injection site) outcome was unknown and LYMPHADENOPATHY (it might have been a little lymph node/now it's rearing its head again/worse this time) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  The patient applied ice on her arm.
Rash, fever 2 weeks after MMR vaccine. Treatment fluids and TYLENOL.
Patient immediately began experiencing hives to bilateral upper extremities post COVID-19 vaccine dose #2.  Stated she took claritin this morning because she also experienced hives with the first dose. No distress was noted, monitored x 30 minutes and remained stable.  SpO2: 95%, HR 98.  After 30 minutes, patient remained stable and was dismissed.
ringing in left ear and some hearing loss in left ear; ringing in left ear and some hearing loss in left ear; This is a spontaneous report from a contactable other health professional (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm, on 03Jun2021 12:00 (batch/lot number: Ew0181), as 2nd dose, single, at age 39 years old, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 on an unknown date (diagnosed prior to vaccination). There were no concomitant medications. Historical vaccine included the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm, on 05May2021 10:00 (batch/lot number: Ew0173), at age 39 years old, for COVID-19 immunisation. On 04Jun2021 13:00, the patient started to have ringing in left hear and some hearing loss in left ear. No treatment was given for the events. The patient underwent laboratory tests which included SARS-CoV-2 test: Positive on an unspecified date (prior to vaccination), and COVID-19 Rapid Nasal Swab: Negative on 04Jun2021. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: The patient had COVID-19 infection prior to vaccination with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  Based on information available, the reported event ringing in left hear and hearing loss in left ear was unlikely causally related to BNT162B2.  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
wheezing; coughing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (wheezing) and COUGH (coughing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced WHEEZING (wheezing) and COUGH (coughing). At the time of the report, WHEEZING (wheezing) had resolved and COUGH (coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details include Inhalers, nebulizer
Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021; Vitamin D levels were also a bit low on the first test; This spontaneous case was reported by an other health care professional and describes the occurrence of SERUM FERRITIN INCREASED (Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021) and VITAMIN D DECREASED (Vitamin D levels were also a bit low on the first test) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney absent (Had only one kidney, because they donated one 12 years ago) in 2009.   On 11-Jan-2021 at 11:11 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021 at 10:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced SERUM FERRITIN INCREASED (Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021) and VITAMIN D DECREASED (Vitamin D levels were also a bit low on the first test). The patient was treated with VITAMIN D3 for Vitamin D supplementation, at an unspecified dose and frequency. At the time of the report, SERUM FERRITIN INCREASED (Ferritin levels were high (400), more than double the maximum expected (150). On 01Mar2021) and VITAMIN D DECREASED (Vitamin D levels were also a bit low on the first test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Serum ferritin: 400 (High) Ferritin levels were high (400), more than double the maximum expected (150). On 01-Mar-2021, Vitamin D: low (Low) A bit low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-MAY-2021 contains non-significant information.
4/9/2022 Patient had fever, Rash, Seizure. Patient also being treated with antibiotics, Continued in antibiotics. Fever went away. Rash by photo not urticaria.
Five months post vax the pt experienced a mild chickenpox outbreak with less than 50 lesions.
Fever, chills, myalgias fatigue, beginning 6 hours-after vaccine. As of 11-8-10 symptoms persist.
Day 8 post vaccination patient reported 4-5 inch red, raised, itchy rash above injection site on left arm. Day 11 post vaccination rash remains without improvement. Patient also reports brief numbness to left hand on day 11 which did resolve same day.
Pt is 43 yo female, s/p full Pfizer COVID vaccination: dose 1 on 3/26 and dose 2 on 4/16. Pt was exposed to person positive for COVID-19. Onset of symptoms on 8/5 of chills, cough, fever, congestion and headache. COVID PCR resulted back positive on 8/9. Throughout course of illness, pt reports intermittent diarrhea, no sense of taste, and ear pain.
12:20pm  Headache, cold sensation in mouth/throat, pressure in chest.  Patient appeared drowsy and complained of having difficulty staying awake.  Vitals: 12:25pm  122/60 81 18  O2 97%;  12:33pm  139/70 85 18  O2 96%;  12:44pm  142/98  82 18  O2 97%;  12:48pm  143/90 82 18  O2 96%; 12:45pm  50 mg diphenhydramine given IM.   12:33 PM EMS called;  12:45pm EMS arrived;  12:50pm EMS departed to Hospital; Pt. was  alert and oriented upon departure.
COVID-19 Treatment; COVID-19 Treatment; Rebound 3days after complete therapy/COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "gout" (unspecified if ongoing); "Known allergies: Quinolones" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; AMLODIPINE; METOPROLOL SUCCINATE; ROBITUSSIN DM; SYNTHROID. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 07Aug2022, outcome "unknown", described as "Rebound 3days after complete therapy/COVID 19"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. (Paxlovid). Therapeutic measures were not taken as a result of disease recurrence.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a causal association between BNT162b2 and the reported events cannot be excluded as drug efficacy varies form one patient to another and is affected by different factors.
Had severe burning pain in injection site on 10/14/10. On 10/19/10 continues to have pain in arm when reaching.
patient age 5 months and 2 days old and was administered with Pentacel that expired 2 days prior to administration with no adverse event; patient age 5 months old and was administered with Pentacel that expired 2 days prior to administration with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00346373) was received from other health care professional and transmitted to Sanofi 04-Nov-2020.  This case involved 5 months old male patient who was administered with vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that expired 2 days prior to administration.  Relevant medical history, past medical treatment, vaccination details and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE 13V (PCV 13).  On 04-Nov-2020, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE single dose vials (Box- lot number UJ125ABA expiry date: 02-Nov-2020, Powder- UJ125AB expiry date: 02-Nov-2020 and liquid vial - lot U6397AB, expiry date: 02-Nov-2020) (Expired product administered) via intramuscular route in the left thigh for prophylactic vaccination (Product administered to patient of inappropriate age as the patient was 5 month old).  No adverse event was reported at the time of reporting.  It was a case of actual medical error as expired vaccine used and inappropriate age at vaccine administration.  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.
Face was bright red and hot; Face was bright red and hot; felt pressure in my head; my ears hurt; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 08:15 am (Batch/Lot Number: EL9266, Lot unknown: False) as 1st Dose, SINGLE for covid-19 immunisation. Medical history included Non-Hodgkin Lymphoma, high blood pressure, known allergies: Sulfa, known allergies: IV Contrast. The patient previously took rituxan and has Known allergies: Rituxan, amoxicillin sodium (AMOXILLIN) and known allergies: Amoxillin. Patient was not pregnant. If other vaccine in four weeks: No. Other medications in two weeks: yes. Known allergies: Rituxan, IV Contrast, Sulfa, Amoxicillin. If covid prior vaccination: No, If covid tested post vaccination: No. The patient experienced face was bright red and hot (non-serious) on 19Feb2021 09:15 am, felt pressure in my head (non-serious) on 19Feb2021 09:15 am, my ears hurt (non-serious) on 19Feb2021 09:15 am. If treatment AE: No. Adverse event: Face was bright red and hot, felt pressure in my head and my ears hurt. For all events, outcome was recovered on an unspecified date in 2021.
Patient in office 2/28/17 reporting ongoing tingling in her back x approximately 1 1/2 wks. (paresthesia). (No tingling elsewhere. No weakness. Neurologic exam NL here).
Inpatient Pharmacy Warfarin Anticoagulation Therapy Protocol Progress Note  SUBJECTIVE: Patient is a 72 Y male admitted on 8/22/2023 for Acute Hypoxic Respiratory Failure/ Covid 19 / PNA+RT MOD Effusion/S/P Heart Transplant Allergies: Vaccine, Cyclosporine, Fluoxetine, Gabapentin, Lisinopril, and Spironolactone   OBJECTIVE: Medication: Warfarin New Start Warfarin?  No  Duration/Expected Duration: Indefinite   Indication: DVT   Goal INR: 2 - 3   Warfarin Tabs at Home: 2mg Home Dose:  Sunday (mg): 2 MG Monday (mg): 2 MG Tuesday (mg): 2 MG Wednesday (mg): 2 MG Thursday (mg): 2 MG Friday (mg): 2 MG Saturday (mg): 2 MG   Managed by/To be managed by: Anticoagulation Clinic   Labs: Estimated body mass index is 22.99 kg/m² as calculated from the following:   Height as of this encounter: 1.778 m (5' 10").   Weight as of 6/22/23: 72.7 kg (160 lb 3.2 oz).  Recent Labs   08/24/23 0605 08/23/23 0727 08/22/23 1154 PT 31.9* 31.8* 30.6* INR 3.2 3.2 3.0      Recent Labs   08/24/23 0605 08/22/23 1154 HGB 9.8* 10.6* HCT 33.4* 36.0* PLT CONFIRMD | 125* | NORMAL 119* CR 2.39* 2.48*    Lab Results Component Value Date   ALT 26 08/24/2023   AST 24 08/24/2023   GGT 22 07/15/2020   ALKALINE PHOSPHATASE 55 08/24/2023   Bilirubin, total 0.3 08/24/2023   Amylase 66 01/26/2023   Lipase 83 08/22/2023   Inpatient Warfarin Dosing History:    Date INR Warfarin (dose) Diet (note diet changes, ex: NPO, low intake, tube feeds, etc) Comments 8/22/23 3.0 HOLD Low Na   8/23/23 3.2 HOLD Low Na   8/24/23 3.2 HOLD Low Na                         Major Drug-Drug Interactions (include start/stop dates): Recent Vitamin K? No Ceftriaxone, dexamethasone, doxycycline, remdesivir, prednisone   Significant comorbidities or disease states: Renal failure   ASSESSMENT Today's INR is supratherapeutic Signs/symptoms of bleeding noted by RN/MD?: No, per chart review   Pt was on warfarin prior to admission       1. Education/re-education provided? No, will attempt to educate over phone today as patient is COVID +.   PLAN 1) Will hold warfarin tonight because supratherapeutic INR 2) No bridging at this time.       3) Recheck PT/INR with AM Labs  4) Pharmacy to continue to monitor Per Protocol 5) Discharge planning: None at this time.                        Cosigned by: (Pharm.D.) at 8/24/2023  2:23 PM  Note Details  File Time 8/24/2023 12:23 PM Author Type (none) Status Signed Last Editor (none) Admit Date 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023  ED to Hosp-Admission (Discharged) on 8/22/2023   Revision History   Detailed Report  Note viewed by patient Care Timeline  08/22   Admitted from ED 2144 08/25   Discharged 1644
Temperature was 102.  No use of limbs.  As tho paralyzed.  Lasted about 12+ hrs.  Then very tired for 3 days along with intestinal problem. Then tummy started churning and the intestinal emptying stopped 11/12.  No bowel movements again until 11/17/21
Received vaccines in AM.  That PM, came back to office with fussiness and leg swelling. That night, continued to have fussiness, leg swelling and low grade fevers.  On 7/23/13 went to ED for fussiness, evaluated for intussusception - work up negative. Seen again in office on 7/24/13.
Patient was given COVID booster for ages 12-18, no adverse reactions just reporting due to COVID vaccine
PT woke up on AM of 9/29/10 with dizziness, nausea, dry heaves, decrease appetite no fever. MD at Urgent Care gave a "shot" for dizziness and a rx for Meclizine 25 mg tid.
Swelling of lips; Sores in the mouth/the sores are underneath the lip by the cheek on top and bottom; the sores are underneath the lip by the cheek on top and bottom/sores being white on top and real red where the bump is, but on top of it, it's really white; body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL8982; expiration date: unknown) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 30Jan2021 11:30 at a single dose for COVID-19 Immunization. Medical history included Hashimoto's thyroiditis and acid reflux. Concomitant medication included levothyroxine for Hashimoto's thyroiditis and pantoprazole for acid reflux. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID VACCINE; lot number: EL1283; expiration date: Apr2021) at vaccination age of 58-year-old via an unspecified route of administration in the left arm on 09Jan2021 at a single dose for COVID-19 Immunization. The patient reported that she got her second shot on Saturday 30Jan2021 and yesterday (01Feb2021), her lips were swollen, and she has sores inside the mouth, the sores are underneath the lip by the cheek on top and bottom. She further reported that swelling was on both top and bottom lips, it occurred yesterday 01Feb2021, she noticed it as soon as woke. The sores in the mouth also started at the same time. She added that the lips swelling is ongoing but getting better. The Sores in the mouth, she thinks that they are getting better but it does bother her more when she is eating, but it is getting better, she only experiences pain on the sores when she is eating but other than that there is no pain. She has not used anything to treat the swelling and sores. The sores are sensitive to touch. She described the sores being white on top and real red where the bump is, but on top of it, it's really white. She has had no positive COVID Test prior to the first dose. She has had no issues with vaccines in the past. She also added that she did have chills and body aches on Saturday (30Jan2021) and Sunday (31Jan2021), she thought she was doing great, but then on Monday the sores showed up. She wanted to report this because no one said to her that would happen. She clarified that she experienced the chills on the same day of getting the second dose on 30Jan2021, then the body aches came Sunday 31Jan2021. The outcome of the events chill and ache were unknown while the outcome of the other events was recovering.