chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blurry vision; Altered taste; altered smell; Tender lymph nodes; Body aches; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste), PAROSMIA (altered smell), LYMPH NODE PAIN (Tender lymph nodes) and MYALGIA (Body aches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste), PAROSMIA (altered smell), LYMPH NODE PAIN (Tender lymph nodes), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, VISION BLURRED (Blurry vision), TASTE DISORDER (Altered taste) and PAROSMIA (altered smell) outcome was unknown and LYMPH NODE PAIN (Tender lymph nodes), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was  provided by the reporter
Mild difficulty breathing, dizziness and slight nausea.  VERY similar to reactions I have had to anticoagulants...except no fainting at least not yet.  Minor chest pain also.
Information has been received from a nurse practitioner via a company representative referring to a 11 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (1 DF, route, lot# and expiration date unknown) for prevention of HPV. On an unknown date, the patient experienced anaphylactic reaction and had to go to the emergency room for seeking medical attention. The outcome of anaphylactic reaction was unknown. Causality was not provided. Upon internal review, the event anaphylactic reaction was considered to be medically significant.
High fever, chills, pain in right calf and knee, swelling in right calf and knee
Initial misuse report received from a healthcare professional on 21 May 2013. It was reported that DAPTACEL was administered to a 70-year-old patient instead of ADACEL. No adverse event was reported. Documents held by sender: None.
7 days after vaccination she had a fever over 104 degrees that lasted over 5 days.  The day the fever started we noticed a rash developing on her face and neck.  The next day the rash had progresed to her truck areas and the following day on her extremities.  We took her to the ER and they diagnosed her with a virus and told us to control her temperature with motrin and tylenol.
Pt was very sleepy/lethargic per parents. Missed 1 feed no fever, no seizure activity. Resolved second day after shots.
Began having chronic migraines along with passing out unconsciously, severe back pain, leg pain with numbness. Had to have Gallbladder removed due to it being diseased. Also developed chronic low blood pressure. Had numerous tests done and received numerous medication in a attempt to stop migraines and fainting spells. From that day forward chronic migraines continued on a daily basis. Hospitalized from migraines and fainting spells off and on over the course of 07/20/2009 to 09/24/2009 with numerous visits to primary care physician for infusion for migraines along with many visits to the emergency room to receive shots to stop migraines. Currently still experiencing fainting spells and migraines. Now under cardiologist care receiving medication for Chronic Low Blood Pressure and high/low heart rate and also taking a preventative medicine for migraines. For 6 months wheelchair bound off and on due to leg numbness and fainting spells.
Information has been received from a health professional and the spouse of a 29 year old female who in 03/01 was vaccinated with a first dose and in 05/01 was vaccinated with a second dose of varicella virus vaccine live. Blood tests done in early 10/01 showed that the vaccine was not effective. The pt was then vaccinated again on 10/17/01.  A few days later, she found that she was 6 weeks pregnant. The date of the pt's last menstrual period was 09/20/01. The patient's estimated date of delivery was determine to be 06/27/02. Unspecified medical attention was sought. Additional information has been requested.
swelling and bruising of bilateral feet from toes to proximal ankle area; swelling and bruising of bilateral feet from toes to proximal ankle area; This is a spontaneous report from a contactable physician received via Pfizer study. A non-pregnant 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EN5318 and Expiration date: not reported) via an unspecified route of administration on 02Feb2021 (at the age of 87 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included HTN, GERD w/ duodenal ulcer, anemia, osteoporosis, and penicillin allergy. Concomitant medications included calcium carbonate;colecalciferol (CALCIUM +D), iron (IRON 325), furosemide (LASIX 20), and MVI for unspecified indications. The patient previously received the 1st dose of BNT162B2 (Lot number: EK9231) on 12Jan2021 (at the age of 86 years old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. On 08Feb2021, the patient experienced swelling and bruising of bilateral feet from toes to proximal ankle area. There was no pain, not hot nor cool to touch, normal pedal pulses and papillary refill, non blanchable, no fever or chills. On an unspecified date in 2021, an ankle brachial index testing was performed to rule out any circulatory impairment; the result was within normal limits. The patient came back to the physician's office on 26Feb2021 and, overall, swelling improved by 75% (left lateral foot/ankle swelling noted and minimal on right foot). Discoloration of blue cyanosis/bruising color was noted minimally on the 3rd digit of the left foot. The right foot still had blue cyanotic/bruised type discoloration at the base of 2nd-3rd-4th digits, extending proximally by 1 inch and approximately 1.5 inches laterally. The outcome of the reported events was recovering.  No follow-up attempts are needed. No further information is expected.
Chest pain; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on 22Jan2021 08:30 at single dose on right arm for COVID-19 immunization. The patient is not pregnant. The patient had no medical history and no known allergies. The patient had no other vaccine in four weeks. The patient had other medications in the last two weeks. Concomitant medication was unspecified. The patient experienced chest pain on 23Jan2021 13:00. The patient had no treatment and did not recover from the event. The patient was not tested for COVID prior and post vaccination.  Information on the lot/batch number has been requested.
twitching and spasming of muscles bilateral legs, stomach, ribs and left arm. Nerve pain in left bicep (injected limb), random numbers and tingling in bilateral feet, shooting nerve pain in groin area. episodes of tachycardia while resting. increased residual headaches
Parasthesias began in my lower extremities intermittently about 36 hours following administration. These spread to my upper extremities and became consistent. Occasionally will appear in lips and trunk. These are associated with sensation of numbness and some discomfort in my extremities. I'm also experiencing significant brain fog, difficulty concentrating, and fatigue. Headaches are occurring about every other day.  Symptoms are present currently and have remained relatively consistent in severity.  Was evaluated by urgent care on December 28 and encouraged to observe. Was evaluated in the ER by neurology on January 4. There leading hypothesis is vaccine related immune response. Neurologic exam was largely normal, being evaluated by a specialist in the coming days.
Patient fainted, and started convulsing, dad held him and as I was about to give EPIPEN, dad said to hold off.
More tired feeling than usual; cough since two days after vaccine; This is a spontaneous report received from a contactable other healthcare professional. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: unknown), intramuscular in the right arm, on 15Jan2021 12:00, as single dose, for covid-19 immunisation, at a hospital. Medical history included HIV infection and fatigue. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY). The patient previously took codeine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced more tired feeling than usual and had a cough two days after the vaccine, on 17Jan2021. No treatment was received for the events. The patient was recovering from the events. The reporter assessed the events as non-serious.
pt rcvd vax; w/ 30mn following 2nd dose of vax, pt devel swollen arm from the elbow; arm was reddned & numb; pt devel rash on chest;
Paresthesias upper & lower extremities & feeling numb. Pt able to support self with weight bearing & could feel when husband squeezed her arms & legs.
Initial misuse report received from a nurse on 03-Oct-2013. The patient at the nursing home was given two doses (injections) of the FLUZONE High Dose Vaccine. (No information was provided regarding the patient). No adverse event was reported.
Immunization Td given 08/26/2003- patient presented 08/29/2003 complaining of arm soreness and 2 inch erythema, no induration, no swelling, no fever, no ailment associated with.
Information has been received from a registered nurse concerning an 11 year old child who on 03/07/2003 was vaccinated with a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Additional suspect therapy was vaccination on the same day with a second dose of hepatitis B vaccine recombitant (yeast) (MSD) (lot # not reported). Concomitant therapy included vaccination on the same day with a first dose of tetanus toxoid (manufacturer unknown) (lot # not reported). Follow up info received from the nurse stated that the pt had a fever on the evening of the vaccines and for the next 2 days. It was initially reported that on 03/10/2003 the mother reported that the pt had developed a fever and a rash. On follow up it was reported that the mother had called the physician's practice to state that the child had developed a rash and a headache. When the child was seen at the physician's practice on 03/10/2003 there was no rash. Additional follow up info received from the nurse indicated that there was evidence of a local reaction and what had been reported as a rash was only red cheeks with dry skin. Additional info has been requested.
This spontaneous report was received from nurse referring to an unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions or concomitant medications was provided. Since 26-DEC-2016, the patients had been vaccinated with improperly stored doses (incorrect product storage) of PROQUAD (lot # M022401 with an expiration date in 01-NOV-2018), for prophylaxis (dose, dose number, route and frequency were not provided). The doses underwent a temperature excursion > -15 degrees Celsius but < -10 degrees Celsius with a time frame of 2 hours and 19 minutes. The digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008630: US-009507513-1702USA008629.
COVID 19 Treatment; COVID 19 Treatment; Name of Drug as Reported ; Moderna; This is a spontaneous report received from a contactable reporter (Nurse) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 35 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EL3246), in right arm and on 28Jan2021 as dose 2, single (Lot number: EL9265), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 058H21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Nov2021, outcome "unknown", described as "Name of Drug as Reported ; Moderna"; 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: (08Mar2023) Positive, notes: but still positive result on an antigen test; (09Mar2023) Positive, notes: I have a solid, positive antigen test result. No symptoms; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient received Paxlovid from 01Mar2023 to 06Mar2023 for COVID-19. The patient had no known allergies.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for events drug ineffective, COVID-19, and interchange of vaccine products. This case will be reassessed upon receipt of additional information.
swelling/puffiness in both eyes - redness - woke up in the morning and continued throughout day - called employee health at hospital where shot was given and was advised to take benadryl and cold compresses on eyes.  No swelling anywhere else -  Was advised to if swelling gets worse or lasts more than 48 hours to call back or go to Dr.
Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021.  Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA.
Bad intermittent headache resembling a migraine; Felt a pain in chest each time patient breathed in; Felt a consistent heaviness orpressure in my lungs; Occasional shortness of breath.; Minor nausea; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 at 10:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. The patient was not allergic to food, medications, or other products. The patient did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 10:30, the patient felt a consistent heaviness or pressure in lungs, occasional shortness of breath and minor nausea which was present at times. On the same day at 10:45, within 15 minutes of receiving the vaccine, the patient felt a pain in chest each time the patient breathed in which lasted for an hour. On 01Apr2021 and 02Apr2021, the patient had bad intermittent headache resembling a migraine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event felt a pain in chest each time the patient breathed in was resolved on 26Mar2021 in about one hour. The clinical outcome of the events occasional shortness of breath, minor nausea, bad intermittent headache resembling a migraine, and consistent heaviness or pressure in lungs were not resolved at the time of this report  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated that her arm went numb on 04/29/21. She went to the hospital thinking it was a stroke. They diagnosed SIRVA. She said she was given a steroid injection for treatment and will begin physical therapy.
Booster dose; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Booster dose -Tingling pain all over the body including the abdominal and sternal area.; Headache; mild chills; Pain and small hematoma in the injection site; Pain and small hematoma in the injection site; Pain when raising arm above shoulder; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer:Unknown), for COVID-19 immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer:Unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster dose"; PARAESTHESIA (non-serious), PAIN (non-serious), ABDOMINAL PAIN (non-serious), CHEST PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Booster dose -Tingling pain all over the body including the abdominal and sternal area."; HEADACHE (non-serious) with onset Dec2021, outcome "not recovered", described as "Headache"; CHILLS (non-serious) with onset Dec2021, outcome "not recovered", described as "mild chills"; VACCINATION SITE PAIN (non-serious), INJECTION SITE HAEMATOMA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Pain and small hematoma in the injection site"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "Pain when raising arm above shoulder". Therapeutic measures were not taken as a result of paraesthesia, pain, abdominal pain, chest pain, headache, chills, vaccination site pain, injection site haematoma, pain in extremity.  Additional details: Adverse event experienced reported as Booster dose -Tingling pain all over the body including the abdominal and sternal area. Headache and mild chills. Pain and small hematoma in the injection site. Pain when raising arm above shoulder. No covid prior vaccination. Covid not tested post vaccination. Known allergies reported as NKA. Other medical history reported as none.  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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Oct2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient had no known allergies. It was unknown if patient had other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovered" (Nov2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 18Nov2022 to 21Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
asthma; Reactive airways disease; COUGH; head cold that included nasal congestion; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (asthma), BRONCHIAL HYPERREACTIVITY (Reactive airways disease), NASAL CONGESTION (head cold that included nasal congestion) and COUGH (COUGH) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced NASAL CONGESTION (head cold that included nasal congestion). On 31-Jan-2021, the patient experienced COUGH (COUGH). On 01-Feb-2021, the patient experienced ASTHMA (asthma) and BRONCHIAL HYPERREACTIVITY (Reactive airways disease). At the time of the report, ASTHMA (asthma), BRONCHIAL HYPERREACTIVITY (Reactive airways disease), NASAL CONGESTION (head cold that included nasal congestion) and COUGH (COUGH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
March 6, 2021 - (Second shot).  Shot was placed on the upper backside of my left  shoulder at 11:50 a.m.  By 3:30 that afternoon, I had horrible pain in my whole left arm.  The area of the shot got very hot and sore.  By 6:00 p.m., I could not raise my left arm above my waist.  Everyone that saw where the shot had been placed, were shocked.  The pain got so bad I ended up going to hospital.  The doctor told me there was nothing they could do since they can' t remove the shot. Following all these problems,  Shortly after that the pain got so bad in my stomach that I had to go to hospital.  The doctor told me he was transferring me to a different hospital, for other treatment..  I was there from 2/14/21 to 2/15/21.  On March 12, 21 I was taken back to original hospital for additional problems.  They have all the records on file.
55 mm redness, swelling around vaccination site. Pt states itchiness at site but denies any other symptoms.