chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Migraine; extreme sensitivity to light; dizziness; vertigo-type sensation; nausea; This is a spontaneous report from a contactable female consumer (patient). A 44-year-old non-pregnant female patient received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: not reported), via unspecified route of administration, administered in left arm, on 23Mar2021 at 10:00 AM, (age at vaccination 44-year-old), as dose 2, single for covid-19 immunisation. The patient was not a pregnant at the time of vaccination. The patient's medical history included history of headache, occasional migraine in history. Concomitant medications included multivitamins. Allergies to medications, food, or other products was reported as none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: not reported), as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 08:00AM onset approximately 22 hours after administration, the patient experienced migraine, included extreme sensitivity to light, dizziness, nausea or vertigo-type sensation. The patient could not work for several hours. The patient received Sumatriptan (IMITREX) as treatment for the events. The outcome of the events were recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to an unspecified patient of unknown age. Medical history, concurrent conditions and concomitant medication were not reported. The nurse reported that on 30-JUN-2009 the patient received a dose of VARIVAX (reported lot# 0228Y, exp date 13-FEB-2011) instead of ZOSTAVAX. No adverse events were reported. The outcome of the event was unknown. Additional information is not expected.
Patient was thought to have only received 2 doses of COVID 19 Moderna and received another that really became his 3rd.  No reaction has been seen at this time.
The morning after having the vaccine I developed back/muscle pain that lasted for 2 weeks.  Made it very hard to pick up things on the floor or bend over or even get up.  I had nothing like this before.  On a scale of 1-10 the pain was an 8.  Lasted 2 weeks and went away.  Doctor thought it was not from the vaccine but I was fine with no symptoms before injection.  I just wanted to share this in case someone else has the same issue.
Information has been received from a registered nurse, concerning two "college age" (unspecified) patients of unknown sex. The nurse reported that on unspecified dates "as children" the patients were vaccinated with the complete series of doses of Hep B (manufacturer unknown) (route and frequency were not reported) (lot # and expiration dates not reported). The nurse reported that in 2012, the patients underwent hepatitis B antibody titer tests and now the patients had a "non-immune" result on their hepatitis B antibody titer tests. The patient sought medical attention through office visit. At the time of the report the patients' outcomes were unknown. Additional information has been requested.
Patient had vaccine on 6/11/10. Starting not feeling well 2 days ago with low grade fever 100.8. This AM woke up with rash in mouth and face down to trunk area. Doctor Dx her with a reaction to MMR.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "IgA Nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 14Feb2023 to 19Feb2023, the patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment. The patient's known allergies was no nsaids.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 10/14/97; 30 min later pt exp dizziness, syncope, sinus pressure, facial paresthesia, weakness &nausea.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: unknown) frequency one total, dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies to COVID-19. On 06-JUL-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies to COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210753139- Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
syncopal event with ground level fall and traumatic injury to back, debilitating fatigue, muscle weakness.
pt recv vax & 2min later passed out in waiting room;caught by mom child came to p/1min per ammonia capsule;remained in lying position for 2-3min;VS taken pulse low 46 @ first then quickly back to nl 68-72;BP 120/70;
I experienced significant adverse side effects after receiving the J&J COVID vaccine, including facial swelling, numbness of my extremity (this lasted a few weeks) and ongoing sever heart palpitations.  I've been trying to get into a cardiologist for treatment and I have an appointment in January.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that on 21-Sep-2021 vial placed in refrigerator. No temperature excursion and no adverse event was reported. No treatment information was reported.
Symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.; Symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm and on 19Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 33 years, in right arm for covid-19 immunisation. The patient had no relevant medical history and no known allergies. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 21Jun2022, outcome "not recovered" and all described as "Symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) positive; (21Jun2022) Positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that symptomatic for Covid-19 (congestion, aching joints, fever, chills/overheating). Tested positive for covid the following morning (on 22Jun2022, at approximately 5am) via at-home antigen test.
Very tired; Bad sweats; Feeling bad; Blood pressure was 146/74 mmHg/ that same morning blood pressure was even higher 152/80 mmHg and in the afternoon was 159/80; Arm was teriibly sore; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure was 146/74 mmHg/ that same morning blood pressure was even higher 152/80 mmHg and in the afternoon was 159/80), HYPERHIDROSIS (Bad sweats), PAIN IN EXTREMITY (Arm was teriibly sore), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was teriibly sore). On 06-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was 146/74 mmHg/ that same morning blood pressure was even higher 152/80 mmHg and in the afternoon was 159/80). On 09-Mar-2021, the patient experienced HYPERHIDROSIS (Bad sweats) and FEELING ABNORMAL (Feeling bad). On 11-Mar-2021, the patient experienced FATIGUE (Very tired). The patient was treated with AMLODIPINE for Blood pressure, at a dose of 1 dosage form; AMLODIPINE for Blood pressure, at a dose of 1 dosage form; ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. On 09-Mar-2021, BLOOD PRESSURE INCREASED (Blood pressure was 146/74 mmHg/ that same morning blood pressure was even higher 152/80 mmHg and in the afternoon was 159/80) had resolved. At the time of the report, HYPERHIDROSIS (Bad sweats) had not resolved and PAIN IN EXTREMITY (Arm was teriibly sore), FEELING ABNORMAL (Feeling bad) and FATIGUE (Very tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Blood pressure measurement: 130/74 mmHg (High) 130/74 mmHg (normal for patient is 120/71 mmHg). On 06-Mar-2021, Blood pressure measurement: 131/68 mmHg (High) 131/68 mmHg. On 07-Mar-2021, Blood pressure measurement: 131/68 mmHg (High) 131/68 mmHg. On 08-Mar-2021, Blood pressure measurement: 131/68 mmHg (High) 131/68 mmHg. On 09-Mar-2021, Blood pressure measurement: 146/74 mmHg (High) early morning, 152/80 mmHg (High) that same morning was even higher and 159/80 mmHg (High) in afternoon.         Concomitant product use was not provided by the reporter.  The patient had bad sweats which occurred again on 10-Mar-2021.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-041707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-041707:Same patient: 1st Dose
Approximately 10 minutes after patient received his COVID-19 vaccine while he was sitting in the observation area, he stated he was feeling dizzy and lightheaded. Pt was extremely diaphoretic, pale/grey, weakening extremities and decreased level of consciousness. Patient started to hypoventilate, close eyes and lean over while sitting. Vitals checked: BP 90/62, HR 44 fluctuating as low as 39, pulse ox 97%, pulse thready, skin clammy and diaphoretic. RN used ammonia inhalant to keep patient alert. Patient was transferred to floor. He became more alert and able to speak clearly and aware of surroundings. Color improved but BP stayed between 39-44 with complaints of hands becoming numb. Clinic lead called 911 and EMS arrived approx 10 minutes later. No sign of anaphylaxis per skin assessment. Pt was A & O x 4, skin color improving, less diaphoretic, extremities warm to touch - HR 66, oxygen sates 98%. Transfer and report given to EMS. Epi-pen not given as advised by 911. Patient eventually had resolution of symptoms and was able to ambulate with wife present. No hospital transport. Incident report written up as vasovagal syncope.
p/ 2nd Anthrax shot, w/in 30min, devel migraine type h/a;5hr later devel weakness, malaise, fever & chills;heavy noc sweats;local rxn 13Jan 0400 upon waking: swelling, erythema (7x9cm diameter) hypersensitive to touch & mod pruritus
High fever at 2:00 AM following second vaccine injection. Nausea, vomiting, pain, swelling and hardening at injection site. Arm soreness lasted 4 days. Fever lasted 3 days. Extreme fatigue lasted from time of injection to present. Asthma attack 1 week post. Full upper body rash including face, neck, arms, scalp, back, chest and torso. Tylenol and Benydryl taken for fever and rash respectively.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 11-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 29-SEP-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Initial information received on 23-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who was vaccinated with a 0.5 ml dose of MENACTRA (batch number: U5984AC, expiration date: 14-Aug-2019, dose in series were not reported) via intramuscular route in the left deltoid instead of KINRIX.) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included PROQUAD for Immunisation. It was a case of an actual medication error due to wrong vaccine administered. It was unknown if patient experienced any adverse events post vaccination. 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. Documents held by sender: none
Site of injection started itching; Site of injection developed rash (3 inchies); Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection started itching), VACCINATION SITE RASH (Site of injection developed rash (3 inchies)) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 VACCINATION SITE PRURITUS (Site of injection started itching), VACCINATION SITE RASH (Site of injection developed rash (3 inchies)) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PRURITUS (Site of injection started itching), VACCINATION SITE RASH (Site of injection developed rash (3 inchies)) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment for the events included acetaminophen (Tylenol), diphenhydramine (Benadryl cream) and ice pack.
having the vaccine but had a light case/ suspected vaccination failure; light case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she went through free having the vaccine but had a light case of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
pt recvd vax & 3 days p/vax pt exp hives & rash (red bumps) all over body,itching;pt is being treated w/Celestone & chlor-Trimeton;hives cont
rash on my arm; My fingers/hands turned an orangey color- looked like COViD fingers; This is a spontaneous report from a non-contactable consumer (patient). A 5-decade-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The medical history included deep vein thrombosis suspected from COVID infection from February of 2020. On Xarelto being treated for clot right now. The concomitant medication(s) included rivaroxaban (XARELTO) taken for clot right now. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported her fingers/hands turned an orangey Color- looked like COVID fingers and she got a rash on her arm on an unspecified date in 2021. Patient was not diagnosed with Covid-19 prior to vaccination and patient not tested for Covid-19 since vaccination. Patient did not receive any treatment for AE. The outcome of event recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
VZV received 6-17-10 - 24 hours later site started swelling and started with red streaking & worsened over next 2 days - seen in Dr office 6-21-10 - lymphangitis diagnosis at site.
Redness, pain and swelling at injection site.  Fever, tiredness, headache, achiness, nausea
Patient states that she received the following vaccinations and medications during her first trimester of pregnancy.  Referred to VHC for possible hydrocephalus.   Infant is approx 6 months of age today with normal growth and development. Anthrax #1 1/26/03  Smallpox 1/26/03 Hep A 1/29/03 Typhoid  2/10/03 Anthrax #2  2/10/03
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: 3013084) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT "ASTRAZENECA", start date: 24May2022; ALBUTEROL [SALBUTAMOL], start date: 24May2022; VITAMIN D3, start date: 24May2022; TYLENOL, start date: 24May2022; AIRBORNE, start date: 24May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) negative; (03Jun2022) positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. The patient did take other medications in two weeks. Patient took Paxlovid, starting on 24May2022 and Treatment stop date was 28May2022 for treatment of COVID-19. Rebound COVID. Started with being symptomatic on 02Jun2022, 5 days after completing Paxlovid. Developed nasal congestion, worsening cough, shortness of breath, sore throat, swelling of neck lymph nodes. COVID swab on 29May2022 was negative, COVID swab today 03Jun2022 was positive. Adverse events start date was 02Jun2022 and patient had outcome not recovered without any treatment, patient had no known allergies.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
I tried to get up at 11:50pm and fell.  My left side felt partially paralyzed.  I was up a couple of hours and was trying to move my leg.  I fell asleep and woke in the am and was able to walk
patient received Pfizer vaccine intended for 5-11 year olds instead of the 12+