chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore Left Arm; Sore throat; Sore gland left side of her neck; Lethargy; Joint pain; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Left Arm), OROPHARYNGEAL PAIN (Sore throat), NECK PAIN (Sore gland left side of her neck), LETHARGY (Lethargy) and ARTHRALGIA (Joint pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included IgG decreased. Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (CUVITRU) for IgG decreased.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm), OROPHARYNGEAL PAIN (Sore throat), NECK PAIN (Sore gland left side of her neck), LETHARGY (Lethargy), ARTHRALGIA (Joint pain) and HEADACHE (Headache). On 16-Jan-2021, HEADACHE (Headache) had resolved. On 22-Jan-2021, PAIN IN EXTREMITY (Sore Left Arm) had resolved. On 29-Jan-2021, OROPHARYNGEAL PAIN (Sore throat), NECK PAIN (Sore gland left side of her neck), LETHARGY (Lethargy) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she was diagnosed with COVID-19 in Mar-2020 (date unspecified) and did not do the test again as she was out of town, however after she recovered from COVID-19, her COVID Antibody test came out to be negative. She also reported that het second dose of Covid-19 vaccine was scheduled on 15-Feb-2021. Details regarding treatment medications were not reported.
Rash, muscle pain, weakness, flu-like symptoms occurring later in day 1 day after immunizations.
Temperature 101 degrees, rapid heart rate, heart ache, ache all over, shaking all over, headache, aches lasted 3 days but 3rd day less severe, fatigue.
COULD NOT WALK OR URINATE, HAD TO BE HOSPITALIZED TWICE. DIAGNOSED WITH TRANSVERSE MYELITIS AND NOW CN NO LONGER WORK
Started feeling achy around 11:00 PM.  Took Tylenol.  Was achy all day Wednesday and took Tylenol every 4-6 hours.  Woke up Thursday morning and couldn't get out of bed.  I was dizzy and nauseous.  I got up 3 times to use the bathroom and couldn't even swallow water until 9:30 PM.  I had 1/2 cup soup and water that evening.  Thursday I was only slightly dizzy but was able to eat and drink.  I didn't feel well enough to leave my house until Sunday.  Today is a week since the second dose and I'm almost back to normal, but still tired.  FYI, I did have COVID last March.  I was quite sick but not hospitalized.  I received phone calls every other day from the DOH during the almost 3 weeks I was in isolation at home.  I gave plasma 3 times after recovering.
Within seconds after injection, the patient began to slump over and was unresponsive for approximately 5 seconds. His dad and I were asking if he was ok and then he became responsive and said he was fine but had no memory of what just happened. He was completely normal after that except for not remembering what had happened. His father said he was going to take him to the hospital to get him checked out just in case.
This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown date, was vaccinated with GARDASIL (dose, route and lot # not provided). No concomitant medications were reported. The physician informed that on February 2012 (about 1 year ago), a patient after being vaccinated with GARDASIL, developed hives. The patient did not receive any treatment for adverse event. On unspecified date, the patient recovered, on therapy. No further information obtained for this AE. The outcome of hives was reported as recovered/resolved. The relatedness adverse event was unknown for GARDASIL. Additional information has been requested.
Eruption of red/papular/urticarial rash 30 minutes after administration on hands, chest, back, feet, and throat without mucosal injury, fever, jt pain or localized reaction at site of injection.
He was too hot / fever/Fever of Max 103.9; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He was too hot / fever/Fever of Max 103.9) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012620A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol, Diabetes, HIV infection NOS, Kidney disorder (The Stage 3 Kidney Disease) and Triglycerides.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (He was too hot / fever/Fever of Max 103.9). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at a dose of UNK dosage form. On 08-Feb-2021, PYREXIA (He was too hot / fever/Fever of Max 103.9) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 102 (High) High, 103 (High) After half an hour his temperature was 103., 103.9 (High) half an hour later 103.9 and 102 (High) he took a cold shower and his temperature was back on 102.. On 08-Feb-2021, Body temperature: 98.2 (Inconclusive) the fever had dropped down to 98.2..         Concomitant medications include BP medication, Cholesterol medication, Triglyceride medication, Diabetes medication, HIV medication, Kidney disease medications.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: TCR Document Received contains no significant information. On 26-Jul-2021: Follow up contains No significant information.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: pt dizzy and fell immediately after admnistration, near fainting but responsive (talking and nodding her head) after a few seconds.  raised pt's legs above heart level as pt was laying on the floor.  pt felt good enough to sit up and sit on a chair and drink some fruit juice. pt reported history of fainting to vaccines due to fright of needles/administration. advised her to call a family member to drive her home. was picked up by a family member
Fever starting about 10 hours after injection that lasted approximately 30 hours. Loss of voice / hoarseness / stuffiness approximately 28 hours after injection. Still ongoing 20 hours after onset. Patient is not bothered by hoarseness, but wanted to report for sharing the information.
Immediately upon receipt of RabAvert vaccine I experienced fasciculations at the injection site. Fasciculations spread throught torso and into legs over the next 12 hours. Paresthesias developed in legs and arms. These symptoms were severe and required an emergency room visit and additional follow-up visits with a neurologist and infectious disease physician. Symptoms gradually decreased over a three month period.
Patient received Moderna Monovalent after the FDA announced a pause in boosting with the Original Monovalent Vaccine and wait until the Covid Bivalent booster dose was available. When the error was discovered, the patient was contacted by phone on 9/7/2022 at 11:30AM to explain the error and that she should return in 2 months to receive the Covid Bivalent booster dose by Public Health Director.  No adverse reactions where reported by the patient.
I experienced a physosic event. Hallucinations,  delirium, memory loss (I remembersome things but not all when talking with my family since then) ,, anger unlike I've ever had before, 'everyone against me'l.  My family was scared for me and of me. I had left my twin neice and nephew and somehow ended up at a park down the street.  Once home was still 'talking to people' and 'acting out as things were real to me at home and neighborhood. No sleep for 3 nights straight. Has a crisis worker visit in hospital and home visit. My family says I finally came myself about 6/2. Still have injuries due to things I did.
I noticed it in the morning I had a slight intermittent cough and I thought it was from the dust in cleaning my mom's house. I was flying home, while on the plane the cough started to get worse. I was wearing a N-95 mask. The next morning, I was feeling tired and still coughing so I did the at home COVID-19 test which came back positive. I went to the pharmacy that afternoon and did a rapid test which was also positive. I called my doctor's office on Wednesday since it was so late in the day Tuesday. The doctor didn't prescribe the PAXLOVID since it was still very new. I was instructed to take zinc, cough syrup and vitamin C. Nothing helped and the fatigue, periodical cough and a fever (nothing over 99) lasted for another seven days. On June 22 it worsens I called the doctor and they told me to go to the ER and have them look at my chest. Around 5:00 I went to the ER they did some test, and I was having uncontrollable cough spasms which would last 5 mins at a time. I have a family history of heart issues so they ran the CAT Scan. The results showed blood clotting pulmonary heart embolism then they also did a doppler and found clotting in both legs. I was admitted under isolation I received oxygen and IV and a blood thinner and antibiotic. On June 27 an umbrella filter was placed in the upper right side of my chest to catch any possible blood clots. I was instructed to come back in September to get it removed. I still have shortness of breath and some coughing and slight fatigue.
Woke up the next morning with abnormal heart beat, pain in chest. Did an ecg using my apple watch and it said Afib. Went to er and doctor did ecg and confirmed Afib. Reset on its own 2 hours later while in the waiting room.
LOSS OF APPETITE; VOMITING; SLEEPING; CHILLS; LOW FEVER; SEVERE HEADACHE; STOMACH PAIN ON RIGHT SIDE; BACK ACHE; BODY ACHES; HOT/COLD SENSATIONS; This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included birth control.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021  for prophylactic vaccination. Concomitant medications included etonogestrel for birth control. On 03-MAY-2021, the subject experienced stomach pain on right side. On 03-MAY-2021, the subject experienced back ache. On 03-MAY-2021, the subject experienced body aches. On 03-MAY-2021, the subject experienced hot/cold sensations. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced sleeping. On 03-MAY-2021, the subject experienced low fever. On 03-MAY-2021, the subject experienced severe headache.  Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications included: ibuprofen. On 03-MAY-2021 05:00, the subject experienced vomiting. On 04-MAY-2021, the subject experienced loss of appetite. Laboratory data included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain on right side, severe headache, back ache, body aches, hot/cold sensations, chills, and vomiting, and the outcome of sleeping, low fever and loss of appetite was not reported. This report was non-serious.
Presented in emergency room with hives on arms/back.  No facial swelling.  Prescribed antihistamine.
Fever spike to 101.5.; This is a spontaneous report from a contactable consumer(patient).   A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age of 50 years old, administered in Arm Left on 05Apr2021 08:30 am (Lot Number: ER8727) at single dose for covid-19 immunisation.  Medical history included allergies: Sulfa Based.  There were no concomitant medications in two weeks.  The patient got Vaccine on 05Apr2021 started having fever 09Apr2021 03:00 PM. Fever spike to 101.5. Had Fever on 10Apr2021 and 11Apr2021. Body temperature returned to normal on 12Apr2021. Event resulted in Doctor or other healthcare professionaoffice/clinic visit. No treatment received for event. Patient had negative Covid test(Nasal Swab) on 11Apr2021 and negative Flu test on 12Apr2021. The patient was not diagnosed with COVID-19 prior to vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome for the event was recovering.   No follow-up attempts possible. No further information expected
Patient presented with erythematous papule rash, stretching from his clavical to his deltoid.  Vesicles noted although with no eruption at this time, as patient presented on Day #1 of rash presentation.  Seen by ID physician, who diagnosed as classic shingles.  No other symptoms, as patient denies fever, malaise, headache.   Given Rx for Valtrex.
Light headed ness, zoning out following for about an hour after getting the vaccine. Localized pain around injection site the next day.
side effects similar to covid 19 symptoms; This is a spontaneous report from a contactable consumer.     A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and the patient's concomitant medications were not reported.  The patient experienced side effects similar to covid 19 symptoms on an unspecified date with outcome of unknown. The patient get tested for covid 19 but the result was unknown.  Information about Lot/batch number is requested.
fever; headache; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 1, SINGLE for covid-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had COVID-19 last fall or earlier this year and was just now getting her first dose of PFIZER COVID-19 vaccine. She had a fever for several days getting to as high as 103.5 for a day, then dropped down. She did missed two days of work and also experienced headache and nausea. Reporter told her that she needed to report her side effects and she agreed but did not want to be contacted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse reporting that unspecified number of patients (no patient demographics known) were most likely vaccinated with ROTATEQ orally which went out of temperature range and were exposed to temperature condition not supported by their in house stability data. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Little small bump; it started to appear more and it's comeback behind on my right side; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received BNT162B2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EW0172), via an unspecified route of administration on 24May2021 as second dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has previously received first dose of BNT162B2 (Batch/Lot Number: ER8736) for Covid-19 immunization. On 25May2021, Tuesday patient had a little small bump come up, that was mosquito bite or something and then the next day had another bump and it started to appear more and it has comeback behind on patient's right side. Hasn't spread but they start to break open and are very sore and very tinted to touch. Patient wanted to report but patient wanted to know Is that normal. Patient stated that it was getting worse. Outcome of the event was reported as unknown.
Rashes itching. Follow the same at home instructions for "food allergies" in September. Two doses of Benedryl in last 24 hours 5 ml. Slight harness at injection sight right hip. Not sure which one was on which side.  Does not seem bothered. No difficulty breathing. Will continue benedryl. Circled hard spot to see if larger or smaller by morning. Will return to Dr. If worsen. Last time was told it was his food Allergies sent home with benedryl. Will definitely follow up with the clinic over the weekend or on Monday if available. Or ER.  The paperwork says DTap - no details on specifics Hepatitis A - no details on specifics
Patient complains of rash at site. Used ice and lotion. Also had cough and congestion.
Presented to ER the day after receiving the flu vaccine.  C/O lethargy, SOB.  Pt with temp of 100.8 degrees F.  Pt having slurred speech, twitching and decreased lung sounds throughout.    Pt reported allergies include sulfa, contrast, theophylline, ACE inhibitors, NSAIDs and iodine.
Three minutes after receiving the first dose of the Pfizer\BioNTech COVID19 vaccine today (time 11:34 am), this vaccine study participant developed swelling of both cheeks and "was able to bite on both cheeks" as well as vague flushing of the cheeks.  She did not immediately report these symptoms but returned to the site of her injection (research study site) and reported the cheek swelling and facial flushing to our study nurse.  She denied  lip/tongue/airway swelling, difficulty breathing, nausea or vomiting, diarrhea, cough, wheezing, shortness of breath, rapid breathing, fever, headache, paresthesias, rapid heart rate, chest pain, or other symptoms at that time.  I am a sub-I for Pfizer\BioNTech vaccine study and authorized an immediate dose of Benadryl 50 mg orally which she received.  I examined her at 12:40 pm and she had a reassuring physical exam as follows:  Constitutional:      Appearance: Normal appearance; well-hydrated and alert; no retractions, tachypnea, nasal flaring, or audible wheezing/breath sounds.  No pallor. HEENT:     Head: Normocephalic and atraumatic.     Nose: Nose normal without visible discharge.    Mouth: Mucous membranes are moist.     Cheeks:  Minimal edema of both cheeks is present; no visible erythema on exam. Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equally round and symmetric. Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm, HR 80-90.    Pulses: Normal pulses in left wrist 2+/2+; warm hands. Pulmonary:     Effort: Pulmonary effort is normal; RR 12-14.    Breath sounds: Normal breath sounds.  Abdominal:     General: Abdomen is flat.  Neurological:     Mental Status: She is alert; speech and comprehension are normal. The patient still felt unusual by 2:00 pm and was referred to our Emergency Room for further evaluation.  In our ER, she had the following vital signs and exam findings: BP 140/87  | Pulse 73  | Temp 98.1 °F (36.7 °C)  | Resp 16  | SpO2 100%  Gen: well appearing, no apparent distress, speaking in full sentences, no dysphonia Head: normocephalic, atraumatic, no hematoma Eyes: pupils equal reactive to light, extraocular movements intact ENT: hearing grossly normal, oral mucosa moist without edema/angioedema Resp: speaking in full sentences, clear to auscultation bilaterally, no rubs/crackles/wheeze, normal effort Abd: normoactive bowel sounds, nontender nondistended, no rebound/guarding, no organomegaly, faint/resolving urticaria abd x2 Ext: no deformities, no joint swelling, no edema, faint patchy erythema bilateral upper arms Neuro: alert, nonfocal Psych: AAOX3, normal affect/mood   I walked to our emergency room and reexamined her, and the only new finding were some pink small nonraised popular lesions on her abdomen and proximal arms, but she had no urticaria.  Her lungs remained CTA and she was otherwise as before.  The emergency room only gave famotidine 20 mg to her and discharged her with an EpiPen to use at home (they specifically felt she did not need it in the ER), but gave her oral cetirizine 10 mg to take daily for the next few days.  I asked her how she felt upon discharge from the ER and she felt fine/normal.
Sore injection sight; headache; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 13:00 (Lot number: EP6955) at the age of 48 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Corminaty (Dose 1; 4:45PM, EP6955, Left arm), administration date: 18Mar2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "Sore injection sight"; HEADACHE (non-serious) with onset Apr2021, outcome "not recovered", described as "headache"; FATIGUE (non-serious) with onset Apr2021, outcome "not recovered", described as "fatigue". Therapeutic measures were taken as a result of vaccination site pain, headache, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient received within 2 weeks of vaccination. Prior to vaccination, patient  was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products. Seriousness criteria-Caused/prolonged hospitalization.  No follow-up attempts are possible. No further information is expected.
Patient was given first dose of Moderna vaccine intramuscularly in left deltoid on June 24, 2021. Patient had already received first dose of Janssen COVID-19 vaccine on April 7, 2021. Patient exhibited no symptoms or side effects and was monitored for 30 minutes post-vaccination.
This solicited report was received from a consumer concerning a 27 year old female patient (currently 42 years old) enrolled in a patient support program. In approximately 2000, at the age of 26 years, the patient was vaccinated with the first dose of GARDASIL (dose, strength, route of administration and lot number were not provided). In approximately 2001, at the age of 27 years, the patient was vaccinated with the second dose of GARDASIL. In approximately 2008, at the age of 34 years, the patient was vaccinated with the third dose of GARDASIL. According to this information, the patent received the second and third dose at an inappropriate age and did not comply with the dosing schedule time. At the time of reporting, the outcome of inappropriate schedule of drug administration was unknown. The causal relationship between inappropriate schedule of drug administration and GARDASIL was not related. Additional information is not expected since no consent for follow up was given.