chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son and I received his vaccination card and when we got home (after the pharmacy was closed for the night) we realized that the pharmacy had marked his card as receiving the Janssen COVID Vaccine and not the Pfizer as scheduled and confirmed upon arrival. Needless to say, we both barely slept all night not knowing what shot my son had actually received. I went first thing this morning to the pharmacy and spoke with the pharmacist on duty (not the same pharmacist that administered the shot the night prior) and she was very appologetic and corrected the situation and corrected my son's vaccination card. This never should have happened and I would like a governmental explanation as to how they are SO sure that my son ACTUALLY received the right injection.  Thank you very much.
Temperature of 101.2 stayed for 48 hours; Severe Rash on Face, Neck, chest and legs (I have a photo); Extreme Fussiness (hysterical crying for over 3 hours); and Fatigue
This spontaneous report as received from a company representative refers to a female patient of unknown age. The patient was vaccinated with, .65 ml ZOSTAVAX on 29-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 03-NOV-2012 the patient experienced shingles, 6 days after onset of therapy. No treatment information was reported. The outcome of shingles is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Patient sought medical attention, went to an urgent care facility. Additional information is expected.
Patient stated he was not feeling well after receiving the first dose of pfizer covid vaccine.  Patient was lowered to the floor, given water to drink.  Paramedics were called patient refused transport to medical facility.
Dizziness and nausea felt like vomiting (But did not) within first 10 minutes of receiving vaccine.Headache and left arm pain came later on.; Dizziness and nausea felt like vomiting (But did not) within first 10 minutes of receiving vaccine.Headache and left arm pain came later on.; Dizziness and nausea felt like vomiting (But did not) within first 10 minutes of receiving vaccine.Headache and left arm pain came later on.; Dizziness and nausea felt like vomiting (But did not) within first 10 minutes of receiving vaccine.Headache and left arm pain came later on.; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PFIZEREW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 09:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as not available. The patient had no known allergies to food, medicine or other products. Concomitant medications taken within two weeks prior to vaccination included loratadine (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE) and paracetamol (ACETAMINOPHEN), all from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dizziness and nausea felt like vomiting (but did not) within first 10 minutes of receiving vaccine on 06Apr2021 at 09:55. Headache and left arm pain came later on, on 06Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events dizziness and nausea felt like vomiting (But did not) within first 10 minutes of receiving vaccine, headache and left arm pain came later on was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
had chills; body aches; nausea; This case was reported by a nurse and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th April 2020, the patient received the 2nd dose of Shingrix. On 25th April 2020, less than a day after receiving Shingrix, the patient experienced chills, general body pain and nausea. On an unknown date, the outcome of the chills, general body pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the chills, general body pain and nausea to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of shingrix and had chills, body aches and nausea the entire evening after the injection.  The reporter was registered nurse and just wanted to relay the information for GlaxoSmithKline product information. The reporter was curious if another booster was needed after these 2 injections. The reporter wanted to know was there any study been done that stated approximately how long this lasts.
A 4 year old patient was administered Adacel, no AE; A 4 year old patient was administered Adacel on thigh, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 4 year old female patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on thigh (product administered to patient of inappropriate age and product administered at inappropriate site).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and POLIO VACCINE INACT (IPV) for prophylactic vaccination.  On 23-Sep-2020, the patient received a 0.5 ml fifth dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6737AA, expiry date: 09-Jul-2022, form: Injection, strength: standard) once via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site (latency same day).  At the time of report, patient had no adverse event (AE) symptoms .  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.
This spontaneous report was received from a healthcare professional and refers to a currently 14 months old, female patient. The patient's medical history and concurrent conditions were not reported. On 26-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L008270 with expiration date 11-MAR-2017 (dose, and route of administration were not provided). No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 41 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: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: CLARITINE, start date: 01Feb2022, stop date: 02Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Negative; (24May2022) Positive; (25May2022) Negative; (26May2022) Positive; (27May2022) Negative; (28May2022) Positive; (02Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 18May2022 to 22May2022.  Clinical course: Patient received vaccines and other medication in two weeks also had no known allergies. Adverse event: Rebound of Covid symptoms & strong positive on rapid antigen test on 28May2022 (day 12 after symptoms started & day 6 after completing course of paxlovid). Tested negative on 23May, faintly positive again on 24May, negative again on 25May, positive 26May, negative 27May & morning of 28May. I've continued to test positive through 02Jun & symptoms have worsened from mild allergy symptoms on 28May (itchy throat) to mild flu symptoms on 02Jun (sore throat, chills, headache, malaise).  Follow up attempts are completed. No further information is expected.
Tingling and numbness around nose. Pins and needles on both arms and some numbness... especially around the injection site.  Symptoms began around 18 minutes after injection and lasted an hour.
clotting at the placenta/caused the baby to not receive any blood; Baby was deceased on: 26Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of FOETAL VASCULAR MALPERFUSION (clotting at the placenta/caused the baby to not receive any blood) and FOETAL DEATH (Baby was deceased on: 26Oct2021) in a foetus patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 026D21D) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy.    No Medical History information was reported.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FOETAL VASCULAR MALPERFUSION (clotting at the placenta/caused the baby to not receive any blood) (seriousness criteria death and medically significant) and FOETAL DEATH (Baby was deceased on: 26Oct2021) (seriousness criteria death and medically significant). The patient died on 26-Oct-2021. The reported cause of death was clotting at the placenta. It is unknown if an autopsy was performed.            No concomitant and treatment medication were provided Patient stated that this is my "rainbow baby" as her previous baby passed away due to doctor negligence in 2019 as she stated that it had nothing to do with health it was doctor's negligence in 2019.  Company Comment: This case refers to a foetal patient of unspecified age and gender with a medical history of mother reporting maternal exposure during pregnancy. The patient experienced the unexpected event of Foetal vascular malperfusion on an unspecified date after the second dose of mRNA-1273 vaccine but experienced the unexpected event of Foetal death approximately 6 days after receiving the second dose of the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-440025 (Patient Link).; Sender's Comments: This case refers to a foetal patient of unspecified age and gender with a medical history of mother reporting maternal exposure during pregnancy. The patient experienced the unexpected event of Foetal vascular malperfusion on an unspecified date after the second dose of mRNA-1273 vaccine but experienced the unexpected event of Foetal death approximately 6 days after receiving the second dose of the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Clotting at the placenta
Pt reported fever to 101-102. Pt reported arm swollen at site of injection.
I have noticed a decrease in hearing acuity. I find myself asking people to repeat things because I didn't hear it clearly.; This is a spontaneous report received from a contactable health care professional.   A 53-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3248) via intramuscular route of administration on the left arm on 20Jan2021 at 12:00 as single dose for COVID-19 vaccination and the patient also received first dose of BNT162B2 (BNT162B2); Lot/batch no: (EL1284) via intramuscular route of administration on the left arm on 31Dec2020 at 11:00 as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications included bupropion for an unknown indication since an unspecified date and is unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not allergic to medication, food, or other products. On an unknown date in Feb2021, the patient had noticed a decrease in hearing acuity and she find herself asking people to repeat things because she did not hear it clearly . It was unknown whether the patient received therapeutic measures for the event. The clinical outcome of the event decreased hearing was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
Fever- (100.7) started 14 hours after vaccine and lasted 24 hours Nausiated- started 14 hours after vaccine and lasted 48 hours Extreme Fatigue- started 14 hours after vaccine and lasted 48 hours
3 patients dosed from the first vial before particle discovery; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (3 patients dosed from the first vial before particle discovery) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (3 patients dosed from the first vial before particle discovery). On 22-May-2021, POOR QUALITY PRODUCT ADMINISTERED (3 patients dosed from the first vial before particle discovery) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  3 patients dosed from the first vial before particle discovery. The particle looks clear with black spots on it and about 1 millimeter in size. No treatment information was provided.
Accidental administration to underage. No known/reported adverse event. However, the day after injection patient presented with seasonal allergies and left ear otitis media, otitis externa with perforation that has since resolve. Clinic learned of event incidentally through local pharmacy. Patient's mother had called clinic requesting second dose in series. Clinic is no longer participating in vaccination administration. Patient family was referred to local pharmacy for second injection. Pharmacist called to inform of underage patient receiving unapproved vaccination.
This case was reported by a consumer and described the occurrence of pain in rib cage in a 79-year-old female subject who was vaccinated with Flu vaccine, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  The subject's medical history included bone spur of neck and hip surgery.  Concurrent medical conditions included arthritis, fibromyalgia and hypertension.  Concurrent medications included SYNTHROID, POTASSIUM, VOLTAREN, VASOTEC, Glucosamine, Multivitamin, Vitamin B, NIACIN, Stool softener, Lortab, Vitamin D, Baby aspirin, COQ-10 and Red yeast rice.  In 2006 the subject received a dose of flu vaccine (unknown manufacturer).  That night following flu vaccination the subject felt achy.  In the morning, the event resolved.  On 24 October 2008 at 14:30, the subject received flu vaccine (unknown GlaxoSmithKline brand). Less than one day after vaccination with Flu vaccine, 4 hours after vaccination with flu vaccine, the subject experienced pain in rib cage, painful feeling, shoulder pain and neck pain.  At the time of reporting the events were unresolved.  Follow-up information was received on 24 November 2008 via consumer who reported she had physical therapy on the same day as her Flu vaccine, and her physician believed the physical therapy might be partially responsible for her symptoms.  She also visits her dentist every three months, on her Thursday visit the dentist mentioned her gums were softer than they were at her last visit.
body aches; chills; headaches; migraines; This is a spontaneous report from a contactable consumer. An adult patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced body aches, chills, headaches and migraines on Jan2021 with outcome of recovering. The events was considered non-serious.  Information on the lot/batch number has been requested.
6? diameter redness appeared around injection site almost a week after injection. Swelling itchy and red. Feels like swollen mass under skin. Temperature of injection site measure 101 Deg Fahrenheit. No fever elsewhere. Body temperature normal. Fever isolated to injection site.
death 2 and half hours after receiving the first Moderna vaccine; A Spontaneous report was received from  a health care professional concerning a 61 year old male patient,who received Moderna's COVID-19 vaccine (mRNA-1273) and reported death.  The patient's medical history as provided by the reporter included diabetes, history of shortness of breath, cardiac history. Concomitant medications included metoprolol, metformin and glipizide.  On 05 Mar 2021, prior to the onset of events the patient received his first dose of their two planned doses of mRNA-1273 (Batch N0: 030a21a) intramuscularly for prophylaxis of covid 19 infection.  On 05 Mar 2021,it was reported that the patient died 2 and half hours after receiving the first Moderna vaccine. The patient had no symptoms during observation 15 minutes after receiving fist Moderna vaccine.The patient's PCP ordered an autopsy.  Treatment information not included.   Action taken with mRNA-1273 in response to the events was not applicable.  On 05 Mar 2021, it was reported that the patient died.; Reporter's Comments: This is a case of sudden death in a 61-year-old male subject with hx of diabetes, history of shortness of breath and cardiac history, who died 2 1/2 hours after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
COVID INFECTION Narrative:  COVID infection after completion of COVID vaccine series 02/17 COVID VACCINE dose #1 03/10 COVID VACCINE dose #2 04/05 COVID test positive, no symptoms, test taken during pre-op screening for cataract surgery
rash on his neck and lower legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his neck and lower legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH (rash on his neck and lower legs). At the time of the report, RASH (rash on his neck and lower legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported. Upon in internal review on 21 May 2021, the age was corrected to unknown age.
COVID 19 Treatment; COVID 19 Treatment; Dose: 3, 4 Moderna, Dose: 1, 2, 5 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GH9703), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6205), in left arm and on 03Apr2021 as dose 2, single (Lot number: EP7533) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Nov2021 as dose 3 (booster), single (Lot number: 939906), in left arm and on 14May2022 as dose 4 (booster), single (Lot number: 049L2IA), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Oct2022, outcome "unknown", described as "Dose: 3, 4 Moderna, Dose: 1, 2, 5 Pfizer"; VACCINATION FAILURE (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: (unspecified date) Negative, notes: after test negative; (21Aug2023) Positive, notes: Positive Test with Symptoms on 21Aug2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Started experience pain in the left armpit, same side as injection. Swollen lymph nodes, a few days later swelling has not subsided yet. Tender to the touch and physical activity is stressful and painful. OTC ibuprofen and acetaminophen have been used to attempt to reduce swelling. OTC medicine has not been very effective.
This spontaneous report as received from a physician refers to a 24 year female patient. The patient's medical history included drug reaction/allergy to erythromycin. On 05-APR-2013 the patient was vaccinated with VARIVAX (Merck) lot # H017706 dose 1. On 06-MAY-2013 the patient was vaccinated with VARIVAX (Merck) lot # H017706 dose 2. Dosing information was not provided. Concomitant therapies included RECOMBIVAX HB, and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, dates of administration were unknown. Approximately on 17-JUN-2013, 6 weeks after the second dose of VARIVAX (Merck), the patient had a negative titer for varicella. No adverse event reported other than the negative titer. Lab diagnostics performed were the titers for varicella, which were negative, but the results were also reported as "unspecified titers for varicella". The patient sought medical attention at the office for the titers for varicella. The outcome of patient had a negative titer for varicella is unknown. Additional information is not expected.
Patient's wife reported  patient having severe cold chills, fever, aching and nausea around 3 am the morning after he received his first dose of COVID vaccine