chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/24/2021 states on that Sunday his tongue became numb and developed pain behind right ear.  Took ibuprofen, went to bed that even.  When he awoke the next morning, Monday, 1/25/2021, the right side of his face was disfigured, puffy, and his mouth was drawn down.  He drove to family member approximately 1 hour away and upon arrival, family member took him to local hospital.  MRI was completed and returned with diagnosis of Bell's Palsy, which was confirmed by three physicians at the hospital.  Was informed may take 6 - 8 weeks for full recovery.  Was discharged with prescription for Lacrilube eye drops, Vibramycin, Prednisone (Deltasone), and Valtrex.  One 1/29/2021 had follow up visit with neurologist and was told to discontinue Prednisone.  Neurologist researched injection follow the 1/29/2021 visit.  Client received call from neurologist on 2/1/2021 and was instructed was able to take second dose of vaccine, physician was not 100% sure same issue would not occur with second dose.
first dose injection site rash and itching on arm; first dose injection site rash and itching on arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (first dose injection site rash and itching on arm) and VACCINATION SITE RASH (first dose injection site rash and itching on arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041LZ0A and 011421A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SUMATRIPTAN (IMITREX [SUMATRIPTAN]), METOPROLOL, AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (first dose injection site rash and itching on arm) and VACCINATION SITE RASH (first dose injection site rash and itching on arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 14-Feb-2021, VACCINATION SITE PRURITUS (first dose injection site rash and itching on arm) and VACCINATION SITE RASH (first dose injection site rash and itching on arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-116575 (Patient Link).
temperature of 107; COVID-19 confirmed by postive COVID-19 test; COVID-19 confirmed by postive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Jan2021 at 12:00 AM (at the age of 81-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included back surgery for which he had a complication and was in a Rehabilitation facility for the first shot. The patient did not have any allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 19Jan2021, the patient experienced a temperature of 107. The patient was taken by ambulance to the hospital and was hospitalized for one week. The patient was tested for COVID-19 post vaccination via a nasal swab test on 20Jan2021 and the results were positive. Therapeutic measures were given for the event temperature of 107 (unspecified). The clinical outcome of the event temperature of 107 was recovered on an unknown date; COVID-19 was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
1 of 5 pts who had a reaction following vax; pt exp numbness of the lips w/in 24 hrs p/vax; no other sx reported;
Pt. states she started to develop hives, onset hotness, and swelling on Lt. deltoid.
I ended up passing out while driving home, hitting a fence and totaling out my car. For about 4 days after was very depressed and would randomly start to cry multiple times during the day.
Sore arm with administration of first Moderna Covid-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with administration of first Moderna Covid-19 injection) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with administration of first Moderna Covid-19 injection). At the time of the report, PAIN IN EXTREMITY (Sore arm with administration of first Moderna Covid-19 injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-176314 (Patient Link).
11/13/03: Broke out with rash on both forearms following injection of Hepatitis B (2-3 days after vaccine administered).  Pt then received Hep B #2 on 01/20/04-same rash appeared 2-3 day after vaccine.  No other symptoms experienced.
Hives Pt. seen 12-20-11 for well child ck & imm. at 1200 noon. On 12-21-11 pt had pancakes for breakfast. Mother gave BENADRYL at 1100 & was helpful for hives. Hives returned in evening - repeated BENADRYL. Itchy & slightly crabby but playful & eating. Denied: fever, runny nose, cough, SOB, tongue/lip/face swelling, wheezing, vomit, diarr., abd pn or joint pn. Continue BENADRYL. Contact clinic if site increase.
Pt states that within an hour of receiving the high-dose INFLUENZA vaccine. Pt complains of cough and congestion. Pt denies sore throat or difficulty breathing. Pt states that she still has symptoms but is feeling better.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna/vaccine administration date=24Mar2022; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). 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 20Sep2022 at 16:30 as dose 5 (booster), single (Lot number: GJ3277) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 at 13:30 as dose 1, single (Lot number: 025A21A), in left arm, on 15Apr2021 at 14:15 as dose 2, single (Lot number: 03B21A), in left arm, on 10Sep2021 at 10:30 as dose 3 (booster), single (Lot number: 048F21A), in left arm and on 24Mar2022 at 10:00 as dose 4 (booster), single (Lot number: 066K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Knonw allergies: Lactose intolerant" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "vaccine brand other=Moderna/vaccine administration date=24Mar2022". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 24Dec2022 to 29Dec2022.  No follow-up attempts are possible. No further information is expected.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219681, 20211219953, 20211220301, 20211220460, 20211220206, 20211220178, 20211220537, 20211220177, 20211220552, 20211220155, 20211220619, 20211220697, 20211220146, 20211220754, 20211220129, 20211220764, 20211220916, 20211220948, 20211219714, 20211219701, 20211219686, 20211219731 and 20211219807. .
12/22/21: Pain at vaccination site immediate.  12/23/21: Headache began to develop  around 7 PM (31.5 hours after vaccine administration) along with skin sensitivity. Frequently interrupted sleep. 12/24/21: Headache, pain at injection site, & skin sensitivity persist. Nausea begins. Took 1 Advil for migraine & 1 Aleve at 10:30 AM.  Headache cleared briefly. Chills began around 1 PM. Headache returned around 3 PM. Nausea persisted throughout day, lack of appetite. Temperature taken at 8 PM at 100.3 degrees. Fever, headache, nausea, & skin sensitivity lasted overnight.  Frequently interrupted sleep. 12/25/21:  Fever & headache cleared by morning (~8:30 AM) (temp 97.6). Skin sensitivity & nausea persisted, though appetite returned. Small amount of food (1/4 C oatmeal in AM), mint tea, (1/4 C roasted potatoes & carrots & one roll) in PM + gingerale. Diarrhea began ~ 5 PM. Bathroom visits every 20-30 minutes. Took 1 Immodium & 2 chewable PeptoBismol tabs ~10 PM. Slept through night. 12/26/21: Skin sensitivity cleared, diarrhea persists. Appetite returned, but still nauseated by food.
developed swelling in his normal arthritic area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing). The patient's concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "developed swelling in his normal arthritic area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1.5 hrs. after receiving 1st Moderna shot while driving, called 911. Swollen throat and back of nose, weakness, dizzyness, feeling heavy like going to fall over, chills and cold flashes, tingling in arms & wrists, could still breathe, breath not labored, no wheezing. Later, still thick back of throat, swollen neck/lymph nodes, very stiff neck & hard to move head, large bruising at injection site, sore arm, fatigue, weakness, pinpointed chest pain (not radiating).
double dose of Adacel  administered to patient/ no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 52 years old male patient who received two doses of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5640AA (Expiry date 27-Jun-2021) via intramuscular route in the left arm on 27-Sep-2019 and first dose of same vaccine with an unknown batch number via unknown route in unknown administration site on 26 March 2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included QUADRIVALENT INFLUENZA VACCINE (FLUZONE QUADRIVALENT) on 27-Sep-2019 .   It was an actual medication error case due extra dose administered.   It was reported that double dose of Adacel received by patient. Medical assistant stated they had a patient who was give the vaccination earlier this year in March and again on 27Sep2019.  At a time of vaccination No adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.  List of documents held by sender: none.
Sudden fatigue, chills, severe body aches, neck stiffness, shakiness, sweating, dizziness, nausea, weakness, pale in color. Subsided in approximately 24 hours.
Metallic taste in mouth shortly after shot, lasted the rest of the day. Fatigue began several hours later. Lasted the rest of the day and through the next day. Injection site was sore for a couple of days.
Patient had received an Adacel dose just with 6 month interval/ No AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves a 57-year-old female patient who had received 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] just with 6 months interval [lot C5757AA and expiry date: 21-Jul-2022] via an intramuscular route in the left deltoid for prophylactic vaccination On 05-Feb-2021 [Inappropriate schedule of product administration].   The patient past vaccination included ADACELfor prophylactic vaccination. Medical history, medical treatment and family history were not provided. Patient received no concomitant vaccines.  At the time of the event, the patient had ongoing laceration.  This was a case of actual medication error due to drug dose administration interval too short [Latency: on the same day].  It was reported that, reporter asked there were any contraindications that should be of concern. The product was used first time and not used still.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  There will be no information available on the batch number for this case.
Heart Palpitations starting on the 28th of May. Chest pain starting on the 3rd of June. And a sick feeling that I have described as a flu or hangover feeling starting on the 5th of June.  All of those palpitations and chest pains have continued at present. Sick feeling lasted until the 30th of June. On about midnight of 22nd of June - I felt extremely faint and went to Hospital ER. Nothing out of the ordinary was found in all the testing for ER and at the urgent. No treatment other than the IV Saline at ER visit.
Moderna COVID-19 Vaccine  I began feeling an increase in heart rate about 5-8 minutes after injection. I reported symptoms and site began to monitor my pulse, which was 160. I then drank 32oz of water and took 400mg ibuprofen. I then began to feel dizziness. Blood pressure was normal. My chair was reclined and I was given about 2oz of orange juice. I was then moved to a stretcher and my legs were elevated on a chair. I took a restroom break. I began by walking, but started to see spots in my vision and sat in a wheelchair. I was able to use the restroom and return to stretcher and elevation of my legs. I was then taken to the ER. I used the restroom once more independently. Blood sample was taken. Heart rate was  160, blood pressure was normal. EKG was abnormal and I was given dosage of adenosine. First dose did not show necessary improvement and I was given a second dose, which dropped my heart rate to the 90s. I used the restroom independently and was given an additional EKG, which was normal. During this time my Physician contacted a Cardiologist, for consultation. I was then discharged with recommendation to follow up with cardiologist in 2-4 days.
I had the Rabavert injections in August 2011. The day after around 6:30 AM I felt dizziness.  Around 10:30 AM These symptoms of nausea, stomach pain, pressure/headache, vomiting, blurred vision (comes and goes away), slurred speech, and chills/shakiness started happening to me, and I fainted around 11:30 AM. My employer took me to a clinic and they gave me medicine to help with the stomach pain.  After the 14th day (last injection of the series) it took about a week and a 1/2 before the stomach pains, vomiting, chills/shakiness and slurred speech went away. Early June 2012 the pressure/headache finally went away, but I still have the dizziness, nausea and blurred vision (comes and goes away).
pt recv vax but interval between dose 1 & dose 2 exceeded one month;pt reported non-detectable levels p/3 doses;
Husband died because of terminal pancreatic cancer; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PANCREATIC CARCINOMA (Husband died because of terminal pancreatic cancer) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes. Concurrent medical conditions included Pancreatic cancer and Cancer (NOS) (for 30 years).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATIC CARCINOMA (Husband died because of terminal pancreatic cancer) (seriousness criteria death and medically significant) and VACCINATION SITE PAIN (Sore arm). On 23-Feb-2021, VACCINATION SITE PAIN (Sore arm) outcome was unknown. The patient died on 23-Feb-2021. The reported cause of death was Pancreatic cancer. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   He was on loads of different medication for cancer which the wife did not know about.  Treatment information was not provided.  As per the patient's wife on 23Feb2021, her husband died because of  terminal pancreatic cancer which she thinks is not related to the vaccine   This case was linked to US-MODERNATX, INC.-MOD-2021-069647  (Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be ruled out. US-MODERNATX, INC.-MOD-2021-069647:; Reported Cause(s) of Death: Pancreatic cancer
Began URI w/fever 24NOV90, treated w/ Robitussin. Coughing, fever & depression  continued 26NOV90 rx Amoxicillin. Better & up walking 28NOV but @ 5PM was pale, dizzy, sweaty & had SOB.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot, expiry date were unknown). The patient was administered ZOSTAVAX at a pharmacy and had informed the reporter that the needle was leaking. The reporter could not confirm if the needle was leaking at the site of administration and whether patient may not have received a full dose of ZOSTAVAX as recommended in the prescribing information. No adverse events were reported. No further information was provided. Additional information has been requested.
Daptacel that was expired 07FEB2020 and given 17FEB2020 to an 18 month old/no AE; Initial information received on 18-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 months old male patient who was vaccinated with an 0.5 mL expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5366AA and expiry date: 07-Feb-2020, frequency once) via an intramuscular route in the left leg for prophylactic vaccination on 17-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for Immunisation.  It is a case of actual medication error due to expired vaccine used. It was reported that patient was given an expired dose of DAPTACEL.  At the time of reporting, no adverse event was reported.  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.
40 year old patient received second dose of Moderna lot number 026A21A.  Began to complain of rapid heart beat, tingling, difficulty breathing, difficulty speaking.  No physical evidence of allergic reaction.  Vitals were normal except mild tachycardia.  No rash or wheeze.  Normal oxygen sat.  Watched longer, offered food, but patient continued to state he did not feel right.  At over 1 hour, asked if he would like to drive to ER, but said he could not drive.  Called EMS.  Gave Bendadryl IM (no po in kit).
I had headache, a scratchy throat, body aches, a bit of a temperature about the first three days. After that, my oxygen sats were running about 92 and 96 oxygen saturation. I had a bit of a cough. My cough wasn't real bad. I felt fatigued.  I called my doctors office and they prescribed Paxlovid for me.
I was totally fine for 4 hours. After 4 hours I started to get injection site pain, headache, tiredness, muscle pain, joint pain, fever, feeling unwell, and swollen lymph nodes. All of this lasted for 2 days. At the end of the 24 hour mark I started having a heartbeat 15-20 bpm higher than my normal, chest tightness, difficulty breathing, and dizziness. I'm now 3.5 days post vaccine dose 1 and still having all of the symptoms in my last sentence plus extreme exhaustion, muscle pain, and fever.
Received initial COVID vaccine at about 1200 today. About ten minutes later started to feeling burning CP, SOB, feeling of tongue swelling, and had a loose stool.  Now feeling lightheaded.  Was feeling fine prior to the  immunization. Anxiety. Anaphylaxis. 30 yo female known hx of allergic reaction/atopy to vaccines presented with anaphylaxis approx 10 minutes after the covid-19 Pfizer vaccine.
Significant pain under my under my scapula and in my clavicle, and all the way up to the base of my neck.  All of these pains were on my right side where the vaccine was administered.  I also have significant weakness, tingling and numbness in my fingers and forearm
27MAR95 mom called w/questions re: immun & reported that following vax on 3JAN95 9PM pt had screaming cry was stiff & limp when picked up;called 911 pt was white & needed 02-hospitalized-t102R