chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient felt dizzy immediately after the HPV was given. She stated she had not eaten. Lied her down flat on exam table. Stated dizziness was going away. BP 115/57. Sitting up BP 102/66. Standing BP 102/76. Walked patient to car.
Tic myoclonus began 6 days post MENACTRA. TAPERED OVER 3 WEEKS AND NOW RESOLVED.
injection site started itching really badly; rubbed the itch; found a bunch of small white bumps all over her arm; patient had a period of heart palpitations; shortness of breathe; was sweating; injection hurt her left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection hurt her left arm), PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe), HYPERHIDROSIS (was sweating) and VACCINATION SITE PRURITUS (injection site started itching really badly) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (injection hurt her left arm). On 12-Mar-2021, the patient experienced PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe) and HYPERHIDROSIS (was sweating). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site started itching really badly), PRURITUS (rubbed the itch) and VACCINATION SITE REACTION (found a bunch of small white bumps all over her arm). At the time of the report, INJECTION SITE PAIN (injection hurt her left arm), PALPITATIONS (patient had a period of heart palpitations), DYSPNOEA (shortness of breathe), HYPERHIDROSIS (was sweating), VACCINATION SITE PRURITUS (injection site started itching really badly), PRURITUS (rubbed the itch) and VACCINATION SITE REACTION (found a bunch of small white bumps all over her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment was provided.
1st dose: 2019; 2nd dose: 26-APR-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix sometime in 2019).   On 26-APR-2023, the patient received the 2nd dose of Shingrix. On 26-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: 2019; 2nd dose: 26-APR-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 26-APR-2023 The patient was over 50 years. The patient received the first dose at the patient's doctor's office. The pharmacist did not had the patient's date of birth and date details regarding first dose. The pharmacist did not had lot or expiry date of the second dose as the vial had been thrown away. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
had waited for 15 minutes and called nurse over with c/o feeling dizzy and itching in throat
Pt to Ed 7/8 for cough, SOB, weakness, chills, nausea, vomiting, and diarrhea x 2 days. Pt COVID positive 7/8, maintained on room air, Decadron 6 mg IV daily, pt A&O x4 vital signs stable. 7/9 Pt had 7 beat run of v tach. 7/10 Pt is A&OX4, stated that he's doing good and doesn't need anything at the moment. 7/11 pt had a 15 beat run. no complaints of any chest pain and or SOB VSS and electrolytes within normal limits, maintained on decadron 6mg IV daily. 7/12 pt discharged home, vital signs stable, discharged on Decadron 6 mg p.o. daily x5 days.
Hospitalization for rhabdomyolysis, acute on chronic kidney failure, elevated liver enzymes, paroxysmal afib, physical deconditioning,  COVID-positive on 9/7/23 on dates 9/6/23- 9/14/23. Treated with dexamethasone, baricitinib, Remdesivir,  vitamin D 25 mcg PO daily.
Bad case of shingles; Information has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On around 02-JUN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine heath maintenance and for the prevention of shingles (herpes zoster) (dose, strength, route of administration, expiration date and lot number were not reported).  On an unspecified date shortly after vaccination, the patient suffered a bad case of shingles. According to reporter, the patient sustained severe and permanent personal injuries. She suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoinment of life, physical impairment and injury. Additionally, suffered and incurred damages, including medical expenses, loss of accumulations and other economic and non-economic damages.   At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX). The event shingles was determined to be disabling.
Information has been received from a nurse concerning a 61 year old male patient with an allergy to LIPITOR, cholesterol high, peptic ulcer disease, coronary artery disease and hypertension who received a dose of PNEUMOVAX in 2003. On 01-DEC-2008 the patient was vaccinated with a 0.5 mL dose of PNEUMOVAX in the left arm. Concomitant therapy including WELCHOL, TIAZAC, aspirin (Aspirin), niacin and TRICOR. On 02-DEC-2008 the patient returned to the office because his arm was swollen, red, warm to touch and painful (onset date reported as one hour after vaccination). The patient had not recovered. The patient sought medical attention through an office visit. This is one of 2 reports from the same source. Additional information has been requested.
Began with some brain fog, soreness at injection site 12 hours after. By 24 hours fever of 102, pain, chills, headache, eye pain, difficulty concentrating
Cough; Blowing her nose a lot; Headache; Temperature of 99; arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow; Just doesn't feel like herself; jittery feeling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), FEELING JITTERY (jittery feeling), COUGH (Cough) and FEELING ABNORMAL (Blowing her nose a lot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD, Fibromyalgia, Anxiety, Panic attack and Complex regional pain syndrome.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), FEELING JITTERY (jittery feeling), HEADACHE (Headache) and PYREXIA (Temperature of 99). On an unknown date, the patient experienced COUGH (Cough) and FEELING ABNORMAL (Blowing her nose a lot). On 23-Mar-2021, FEELING JITTERY (jittery feeling) had resolved. At the time of the report, CONTUSION (arm was sore and bruised, arm was purple that night when she took bandaid off there was bruise, now it's yellow), FEELING ABNORMAL (Just doesn't feel like herself), COUGH (Cough), FEELING ABNORMAL (Blowing her nose a lot), HEADACHE (Headache) and PYREXIA (Temperature of 99) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: (High) 99. On 19-Mar-2021, SARS-CoV-2 test negative: 27-feb-2021 Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications provided were for pain, anxiety, 2 inhalers, breathing machine treatments and oxygen.  Treatment medication were not reported.
Headache chills and fatigue 1/12/21 headache day 5-8 swelling at injection site day 8 Narrative:  tylenol, benadryl, compresses
My menstrual cycles have always been very consistent. After my first Pfizer shot I didn't get my period for around 2 months. I got it during the third month but after that I haven't gotten it in over 2 months. My periods have been very irregular after my first dose.
Pfizer-BioNTech COVID-19 Vaccine EUA  neck pain left side after shot
Patient returned to the pharmacy on 3-2-18 to let us know that he had developed reactions to the vaccine - at the site of injection. S/S: Red, Hot, Pain, Swelled (4 inches in diameter).
Pt received Moderna COVID 19 vaccination at approximately 1145am 1/23/21.  Patient complained of labored breathing and dizziness approximately 10 minutes after receiving vaccine.  No medication/intervention given on site in vaccine clinic.  Pt taken to 1st floor urgent care for evaluation.
Discharge Provider: Private MD Primary Care Provider: Private NP Admission Date: 8/8/2022 Discharge Date: Aug 13, 2022  PRESENTING PROBLEM: Rhabdomyolysis [M62.82] Non-traumatic rhabdomyolysis [M62.82] COVID [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: 73 y.o. male with a pertinent past medical history of cognitive delay, DM2, hypothyroidism, obesity who presented with recurrent falls and weakness after recent COVID diagnosis. Lives alone, did not visit his sister 8/7 (abnormal, usually visits daily), then was found on floor by family. Reports he fell and hit head but didn't lose consciousness. Went to ED, negative CT head and c-spine. Was able to ambulate independently and sent home. Unfortunately fell upon getting out of car-> brought back to ED.    Pt had elevated CK, was treated for rhabdomyolysis w/ aggressive fluid resuscitation. Initially LFTs elevated but improved over time.   Treated for COVID while inpatient with Remdesivir (8/9-8/13) and O2 monitored.   PT/OT evaluated and recommended skilled nursing.
Chest pain/ chest muscle spasms - shortness of breath for brief period after the spasm
This spontaneous report as received from a pharmacist via a field representative refers to a 60 year old female patient. There was no medical history. On 11-JUN-2015 the patient was vaccinated with one shot of ZOSTAVAX (route not provided). On 14-JUN-2015, the patient experienced injection site swelling and redness and could not move the arm without pain. The patient went to an unspecified primary physician for medical attention. There was no intervention to prevent serious criteria, no significant disability or incapacity, no hospitalization or prolongation. The event was not considered life threatening. PQC not involved. The outcome of the events and the relatedness with ZOSTAVAX was unknown. Additional information has been requested.
Caller reports that she went to have a COVID-19 test on 13May2022 and received positive test results on Saturday 14May2022.; Caller reports that she went to have a COVID-19 test on 13May2022 and received positive test results on Saturday 14May2022.; Sore throat; Tickling in her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), 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: "Heart disease" (unspecified if ongoing), notes: Heart disease. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 12May2022, outcome "unknown", described as "Sore throat"; THROAT IRRITATION (non-serious) with onset 12May2022, outcome "unknown", described as "Tickling in her throat"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13May2022, outcome "unknown" and all described as "Caller reports that she went to have a COVID-19 test on 13May2022 and received positive test results on Saturday 14May2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) Positive, notes: Caller also reports that she performed an at home COVID-19 test; (14May2022) Positive, notes: positive test results on Saturday 14May2022.  Additional information: She said that she does have a medical history of heart disease (Intent: Medical history). So, on 12May she started having complaint of the sore throat and it was tickling, her throat was tickling that's what she said. She got a, she want to had on Friday on 13May, she went ahead and had a COVID 19 test. On Saturday she got the results and she was positive. She also did a home test on Friday 13May2022 she said that was positive as well. she also said she has received a primary series of Pfizer COVID 19 vaccine as well as the booster dose of the COVID 19 vaccine. That is all the information I have."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0153), in left arm and on 23Nov2021 as dose 3 (booster), single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history included: "low thyroid" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 25Apr2023 to 29Apr2023.
first dose of Shingrix on Jan2018 and has not received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in January 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The health care professional had no vaccine data. The reporter did not consent to follow up.
Myalgia, Fever, CHILLS, TEMP 101.3, BODY ACHES, AND FATIGUE Narrative:
VACCINE WAS STORED FOR FREEZER TEMPERATURE FOR TOO LONG. WE HAVE RECOMMENDED TO THE PATIENT TO GET REVACCINATED.
Reddening of skin around shot site.. became very itchy.. treated with Hydrocortisone cream around the red area which grew in size of a half dollar coin by bedtime on the 14th.  Upon waking on the 15th it was still red and itchy so continued with cream as needed all that day.  On Wednesday the 16th the redness started to diminish and so did the itchiness. By the 17th the color has returned to normal and the itchiness has gone.  It was suggested I should have taken a Benadryl the first day to minimize the reaction.
A fifteen year old was administered a Menactra booster a year too soon. His last injection was 3 years ago with no adverse event; Initial information received on 25-Jul-2022 and live follow-up received on same day (processed together) regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who was administered a menactra booster a year too soon. his last injection was 3 years ago with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Jul-2019, the patient received a 0.5ml 1 X(once) dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation was unknown, lot U7208AA and expiry date: 20-Feb-2023) via unknown route in unknown administration site for Immunization.  On 21-Jul-2022 the patient developed a non-serious event of a fifteen year old was administered a menactra booster a year too soon. his last injection was 3 years ago with no adverse event (inappropriate schedule of product administration) (Latency:  3 years) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken : not applicable.  Outcome: Unknown  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 the guidelines. 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.
positive COVID test; COVID symptoms; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 17Dec2021 (Lot number: 331308A) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Route of Administration: Intramuscular), administration date: 19Mar2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9266, Route of Administration: Intramuscular), administration date: 25Feb2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 17Dec2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 25Dec2021, outcome "recovered", described as "positive COVID test"; COVID-19 (medically significant) with onset 24Dec2021, outcome "recovered", described as "COVID symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) positive, notes: Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Presented to ED w/ intractable n&v; admitted for same dx and COVID PNA;10/17 - tx w/decadron & pepcid; required only 2L NC supplemental O2 during stay otherwise was not treated for COVID; discharged on RA
Coughing, chest pain, back pain, chills, headache, eye pain, difficulty swallowing, feeling as if throat was closing up.
Erythematous, papular rash, confluent in some regions located to upper ext, head and neck. Blanch able non pruritic. Tx with 24 hour with Benadryl 50 mg Q 6 hours with relief. Trial of Prednisone 60 mg QD x 5 days.
shock collapse, hyporesponsive collapse;loss of color, turning pale, white/blue;prolonged sleeping w/diff of arousing;resp arrest;
30+ minutes after getting covid vaccine, severe chest tightness, hard time breathing in, was driving home and it kept getting worse. Chest pressure. Stopped in local er and got checked out.
Pt given IPV SQ in right thigh, area became red, hot, hard and swollen within 10 minutes. Treatment: Benadryl and Motrin given, ice pack applied, swelling down in 30-40 minutes.
Patient did not have an adverse reaction.   Patient stated he did not have any type of reaction.  He was given and Adult dose of Hepatitis A vaccine prior to turning age 19.  VFC advised to complete the VAERS report.
positive on 05Jun; positive on 05Jun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Cardiomyopathy hyper-trophy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "positive on 05Jun". The event "positive on 05jun" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive; (10Jun2022) Positive; (11Jun2022) Negative; (14Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. No other medications the patient received within 2 weeks of vaccination. Clinical course: Began feeling ill 31May (congestion/cough) tested positive on 05Jun. New to area so went to ER (emergency room) and they gave me Paxlovid. Took for 5 days. Friday 10Jun still positive and congestion/cough returned. 11Jun tested negative but still congestion and cough. Not feeling better and on 14Jun tested positive again. Feeling horrible congested to the max and can not stop coughing. May go back to ER (emergency room) tomorrow if not better. No treatment was given.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.