chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic to the following: influenza shot, pneumonia shot, Solu-Medrol, tetanus shot, and penicillin; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received methylprednisolone sodium succinate (SOLUMEDROL) via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication, pneumococcal 13-val conj vac (dipht crm197 protein) lot/expiry: unknown, via an unspecified route of administration on an unspecified date at single dose for immunization, influenza vaccine (INFLUENZA), via an unspecified route of administration on an unspecified date at unknown dose for an unspecified indication, tetanus vaccine, via an unspecified route of administration on an unspecified date at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient has many allergies. She said that she is allergic to the following: influenza shot, pneumonia shot, Solu-Medrol, tetanus shot, and penicillin. She asked if it would be safe to take the COVID-19 vaccine. The action taken in response to the event for methylprednisolone sodium succinate was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No further information expected.
Patient called pharmacy in the evening after receiving the immunizations on 11/30/2017 to report that she was experiencing swelling in the arm, chills, headache, and flu like symptoms. Patient called her primary care physician the next day, was told to take ibuprofen for the inflammation and pain and use cold compress, pharmacy called patient on 12/1/2017 to inquire on status, patient reported feeling better, less swelling, and a decrease in pain. Patient was told to inform both physician and pharmacy if symptoms do not continue to improve or if they worsen.
paralysis from the neck down; a severe allergic reaction; This is a spontaneous report contactable consumer or other non health care professional. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient experienced severe allergic reaction with paralysis from the neck down. Events resulted in hospitalization on an unspecified date. Reporter concerned about various information she was finding around the FDA approval of the Comirnaty Vaccine and states her employer was planning on mandating vaccination against COVID-19, but she was concerned because she had two cousins that had heart attacks and another (patient), who had a severe allergic reaction with paralysis from the neck down to an unspecified COVID-19 Vaccine, They were hospitalized. The outcome of all the events was unknown.  Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
low cardio; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (low cardio) and FATIGUE (fatigue) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (low cardio) and FATIGUE (fatigue). At the time of the report, CARDIAC DISORDER (low cardio) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: 197 (Low) decreased.         No concomitant medications were reported. No treatment related information has been reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
arm pain started than my heart rate elevated. Resting heart rate was in the 90's but could go all the way up as high as 130. Bad stomach pain, reflux, body aches, headache, fever upwards of 101.2 and nausea. elevated heart rate most concerning. Same side effects were observed with the first one but it did not start for 5 days after the shot and lasted about a week. This time the doctor gave me an ARB to take which calmed down the side effects.
None reported. Given FLUZONE intradermal when he should not, as pt is > 65.
Within 5 minutes, patient's right arm from above elbow to top of shoulder became erythematous and itchy. The redness and itching progressed into her neck and her throat became itchy. Benadryl 25mg was given at 5 minutes. After 45 minutes, patient's arm remained red, but itching was gone.
I have numbness from my elbows down to my hands, numbness from my knees down to my feet; Feels strange; Rapid heartbeat; shortness of breath; Joint aches; A massive headache; Fever (unknown temp); Nausea; Felt super super tired; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet), FEELING ABNORMAL (Feels strange), PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath) and ARTHRALGIA (Joint aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 023D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet), FEELING ABNORMAL (Feels strange), PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath), ARTHRALGIA (Joint aches), HEADACHE (A massive headache), PYREXIA (Fever (unknown temp)), NAUSEA (Nausea), FATIGUE (Felt super super tired) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, HYPOAESTHESIA (I have numbness from my elbows down to my hands, numbness from my knees down to my feet) and FEELING ABNORMAL (Feels strange) had not resolved and PALPITATIONS (Rapid heartbeat), DYSPNOEA (shortness of breath), ARTHRALGIA (Joint aches), HEADACHE (A massive headache), PYREXIA (Fever (unknown temp)), NAUSEA (Nausea), FATIGUE (Felt super super tired) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.            No Concomitant medications were reported. No Treatment details were reported.
patient experienced: Rash; This spontaneous report was received from a consumer, referring to herself, a 54-year-old female patient. The patient's previous drug reactions, or allergies were not reported. The patient's pertinent medical history included: oral herpes, migraine, flares, optic neuritis, abdominal pain upper, muscle spasms and hit by a deer. Concurrent conditions included: heat can cause multiple sclerosis symptoms, sleep apnoea syndrome, restless legs syndrome, muscle spasticity, gait disturbance, relapsing-remitting multiple sclerosis, gait disturbance, anxiety, depression, gastrooesophageal reflux disease, blindness unilateral, colour blindness, type 2 diabetes mellitus, immune system disorder, herpes simplex, pain, corrective lens user, post-traumatic stress disorder, wheelchair user, asthma exercise induced and continuous positive airway pressure (CPAP). Concomitant medications included: Concomitant therapies included rituximab (RITUXAN), ocrelizumab (OCREVUS), topiramate (TOPAMAX), escitalopram oxalate (LEXAMIL), clonazepam, dicyclomine hydrochloride, albuterol sulfate (PROVENTIL), cholecalciferol, pyridoxine, cyanocobalamin, magnesium, glipizide, metformin, valacyclovir hydrochloride (VALTREX), pramipexole, dalfampridine, gabapentin (NEURONTIN), baclofen, escitalopram, tolterodine tartrate (DETROL), omeprazole (PRILOSEC), acetaminophen (TYLENOL) and ibuprofen (IBUPROFEN).  On an unknown date the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (strength, dose, vaccination scheme, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 15-OCT-2019, it was reported that the patient experienced rash.  The outcome of the event was unknown. The causal relationship between therapy with zoster vaccine live (ZOSTAVAX) and the aforementioned event was not reported.
Patient called day after vaccination an complained of headache, chills, nausea & vomiting, and body aches. Patient went to outpatient clinic and was seen to rule out influenza.
After 15 minute wait period, pt left with mother.  When they got outside, pt started feeling lightheaded.  Pt's mother brought pt back to clinic, PCT escorted them to exam room and had pt lay on exam table.  When NP arrived in exam room, pt was alert, face pale.  NP placed cool wet washcloths on forehead and neck.  After a couple minutes, color started to come back to face, had her continue to stay lying down for another few minutes.  Had pt sit up on exam table for 5 minutes.  Mother bought her orange juice, which she drank a little while in clinic.  Had pt stand in exam room for 2 minutes.  Then they moved to waiting area for another 15 minutes.  Checked back with patient and she was feeling ok.  Pt left with mother without difficulty.  Pt has not had this reaction with any other vaccines.  Has passed out at school at sight of blood.
Varicella vaccine 5/15/03. Local reaction (induration, erythema, couple vesiculo-papular lesions) 5/28/03. Area 2 x 3 cm.
Pt has redness, swelling, tenderness around injection site about 4 in. in diameter.  The tenderness radiates into armpit.  Pt has contacted Dr. & is trying BENADRYL and ice to treat.  (Around ZOSTAVAX injection site).
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 03-JUN-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
1 day after receiving both COVID19 vaccines had blood in my urine. After the first vaccine, the doctor prescribed an antibiotic for a urinary tract infection. The 24 hour urine culture results indicated it was not a UTI. The blood resolved after 3 days. I received the 2nd COVID19 vaccine on August 2nd. 1 day after receiving both COVID19 vaccines had blood in my urine. Went to the doctor and she confirmed it was not a bacterial infection. Currently still having blood in my urine as of 8/4/21.
When I had COVID-19, it started with a sore throat. It was different from the sore throat that I normally get when I'm coming down with a cold; this sore throat had a stabbing pain. I had also had headache, dry cough, and extreme fatigue. I later had a low-grade fever of about 100. I didn't call the doctor, because I thought it would be useless, so I just stayed home and self-isolated. I treated my symptoms with OTC ibuprofen and Robitussin DM for day and night. The symptoms lasted maybe five to seven days. However, I continued to test positive between 12 days and two weeks after the symptom onset.
had numbness in hands; stomach was terrible; Felt like labor pains; lots of sweating; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date the patient medical history and concomitant medications was not reported. The patient experienced had numbness in hands, stomach was terrible, felt like labor pains, lots of sweating. The outcome of all events was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
The medication was outdated as of September 09, 2022.  Notified system.  Recommended to give Hep A at the end of the month.
11/10-11/22/21  Pt was admitted to hospital for acute onset of chronic diastolic CHF and right foot diabetic wound.   She was tested for COVID 19 before being transferred to a rehab facility.  Her test came back positive, patient is asymptomatic.  The patient remains in the hospital as case management works on placement in a rehab facility which will take COVID positive patients.
SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 201A21A, expiry unknown) dose was not reported, 1 total, administered on 07-AUG-2021 for prophylactic vaccination. On 07-AUG-2021, the patient experienced chills, headache, sore arm and upset stomach following vaccination with first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient recovered from sore arm on an unspecified date, headache recovered in AUG-2021, chills and upset stomach on 08-AUG-2021.  The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: unknown) dose was not reported, 1 total, administered on 06-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-NOV-2021, the patient reported that after second dose of covid-19 vaccine, the patient experienced sore arm (dose number in series 2). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on NOV-2021. This report was non-serious. This case, involving the same patient is linked to 20220528160.
NO LOT NUMBER PROVIDED.  BOTH DOSES OF VACCINE ENTERED INTO THE STATE SYSTEM AS  "HISTORICAL DOSES" BY MEDICAL GROUP.  BREAKTHROUGH CASE; COVID RELATED DEATH
Information has been received from a physician concerning a 4 year old male who in September 2006 was vaccinated with a dose of Varivax. Concomitant vaccination included a dose of MMR II. Subsequently one week later, in September 2006, the patient developed a generalized, varicella-like rash containing greater than 50 lesions. Unspecified medical attention was sought. The patient was treated with diphenhydramine hydrochloride (BENADRYL). The patient's outcome was not reported. There was no product quality complaint involved. Generalized, varicella-like rash was considered to be an other important medical event by the reporting physician. Additional information has been requested.
Moderna COVID-19 Vaccine Returns to clinic at 0739. Had first dose of Moderna vaccine at 0715 today.  She states that immediately after her lips felt tingly.  She states that she was driving home and she began to feel tingling and numbness into her face around her mouth.  Patient denies having any allergies. Was walking her to the ED and she was talking to nurse, all of a sudden she leaned forward and was coughing and grabbing her throat. Rapid response team called, patient transferred to ED. She gets influenza thoughts without difficulty.  She denies any current URI symptoms no history of heart or lung problems high blood pressure or diabetes.  She denies numbness or tingling in her hands currently.  Currently very nauseated. Patient was given some BENADRYL and some Zofran was watched she still complained of some perioral numbness some labs were obtained potassium is minimally low at 3.5 calcium is also low at 8.1.  This time I suspect this is more of an adverse reaction to immunization shot however if the tingling or numbness persists then a recheck of her electrolytes may be warranted follow-up primary care physician.
Went, to clinic and received the Flu and pneumo vaccine the 27th of November 2007. The, same day of the vaccines in the afternoon started having reactions which were: very red as if being in a tanning bed all day - felt warm with a low grade fever. He was urinating frequently until late that night. Had muscle pain-aching felt very tired and weak. Did not feel like eating. The next day the redness was going away but continued to have flu like symptoms. Finally went to Dr. because of swelling of fingers and joint pain. Could not walk - feed his self or bathe. Dr. put him on methotrexate. Dr. sent him to a Rheumatologist. She continued methotrexate and added prednisone then changed to EMBREL shots. And is still having these problems as of today and all this started after the shots.
DIARRHEA/ STOOLS MOSTLY  WATERY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 07-JUL-2021, the subject experienced diarrhea/ stools mostly watery. Treatment medications included: loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea/ stools mostly watery was not reported. This report was non-serious.
Muscle pain throughout are and left hand cramping through fingers. Mild whole body muscle aches. Approx. 4 hours after injection.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medication  were not reported. On 31-AUG-2016, the patient was vaccination with an expired dose of ZOSTAVAX (lot # L000450, expiration date 09-MAR-2016, subcutaneous, dose not reported). There were no known adverse effects. Additional information is not expected because there is no permission to contact the reporter.
arm at the injection site still to this day feels like it is continuously being stabbed it hurts so bad; constant migraine that comes and goes every day for hours; Feeling extremely exhausted; diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Aug2021 08:00 (Batch/Lot number: unknown) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin; Amoxicillin. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "arm at the injection site still to this day feels like it is continuously being stabbed it hurts so bad"; MIGRAINE (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "constant migraine that comes and goes every day for hours"; FATIGUE (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "Feeling extremely exhausted"; DIARRHOEA (non-serious) with onset 02Aug2021 13:00, outcome "not recovered", described as "diarrhea". Therapeutic measures were not taken as a result of vaccination site pain, migraine, fatigue, diarrhoea. Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported had not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. The first three days after the shot patient had a constant severe migraine that would not go away. The reported events did not result in any seriousness criteria.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines with no reported adverse event; received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines with no reported adverse event; Initial information was received on 16-Nov-2021 regarding an unsolicited valid  non-serious case from a other health professional via Agency (under reference:00860371).  This case involves a 32-year-old male patient who received DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and not the prescribed DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] due to the staff member getting confused on the labeling between the two vaccines (product label confusion, wrong product administered)  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 15-Nov-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (0.5mL, lot U6603AA, expiry date: 05-Mar-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered).   It was an actual case of medication error due to product label confusion and wrong vaccine administered (same day latency)  It was reported "A clinic reporting a medication error described as a 32-year-old male received Tenivac and not the prescribed ADACEL due to the staff member getting confused on the labeling between the two vaccines. The caller did not report a defect with the products but that the clinic was confused and chose the wrong product."  At 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 the 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 lot number for ADACEL  this case.
Basically felt like I got the flu - Nausea, vomiting, fever, dizziness, headache
11/27/21 presents to EC ED for "cough, shortness of breath, mylagias, chills, fever, nausea, vomiting, numbness and tingling in her hands". PMHx of "asthma, MS"
pt recv vax 15JAN96 & 16JAN96 pt devel swelling, redness, achiness & tenderness from area from lt elbow to wrist;pt recovered 20JAN96;
Immune response: Headache Sore/stiff neck Swollen/painful joints (back, neck, shoulders, knees) Chills Unusual fatigue