chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after receiving the moderna shot, patient states she felt funny (unsteady in her walking). She went into the produce department and started to sweat. She walked outside to her car and felt sick to her stomach.  She got into her car, backed out of the parking space. But then she only drove a few minutes and parked the car again because she couldn't feel the brakes of her car with her feet.  She also felt numbness in her hands. Her friend came, and told her that her mouth looked twisted.  The paramedics were called. They did some tests and told her they were transporting her to the hospital as a stroke victim.  The outcome is that her doctor told her she had a stroke, and that the doctor informed her they didnt know if the stroke was a result of the vaccine.  After one week she regained feeling in her fingers, and she has been attending speech therapy since February 2022.  She was cleared to drive February 28 and will be heading back to work shortly.  She still has to do some occupational therapy to do because she can't write yet.  Her neurologist said she was mostly affected in the motor part of her brain.  She states she has high blood pressure but that it is controlled.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was received either RECOMBIVAX HB (intramuscular, dose detail and lot number unspecified) or PEDIARIX (dose detail and lot number unspecified) on the following dates: 23-JUN-2012, 14-JUL-2012, 06-OCT-2012, 18-NOV-2012, 11-SEP-2013. It was unknown which dates correspond to RECOMBIVAX HB and which dates correspond to PEDIARIX. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Patient received 2 vaccine injections to left deltoid muscle 1 1/2-2" apart on 11/23/2008 12:30PM; 10hrs later pain and swelling of left arm and left breast area. Described as burning; arm immobilized with pain. On 11/24/08 patient returned to pharmacy and was instructed to go to Dr's office for treatment; at Dr's office she received a steroid shot and on 11/25/08 patient awoke with symptoms diminished and had no complaints.
Child developed shingles; age 34 months C-8-T, dermatone. Acyclovir 100 l 5ml qid till gone.
fever of 100 degrees; This is a spontaneous report from a contactable consumer, the patient. A patient of unknown age and unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 17:45 as a single dose for COVID-19 immunisation. Medical history included blepharitis, baker's cyst, high cholesterol and osteoporosis from unknown date and unknown if ongoing. Concomitant medications included azithromycin (AZASITE), azelastine (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN), dexamethasone, neomycin, polymyxin b (NEOPOLYDEX); all from unknown date for unspecified indication and more. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 12:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:15, the patient experienced fever of 100 degrees. On 14Apr2021, the patient underwent body temperature and the result was 100 degrees. 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 reported event.  The clinical outcome of the event fever of 100 degrees was recovering.  No follow-up attempts are needed. No further information is expected.
Patient presented to the ED on 3/14/2021 for chest pain and was subsequently hospitalized for essential hypertension and angina of effort, S/P CABG x 3 within 6 weeks of receiving COVID vaccination.
Pain from under arm all the way to wrist swelling from where shot was taken to elbow. Redness & fever.
Burning and itchiness after Injection which went away within an hour. Several hours later I became very disoriented, dizzy, flush, sevwr headache, diahhrea, nauseous (dry heaving), extremely achy in arm , neck and shoulder. Some symptoms are still present 36/hours later.
Information has been received from a certified medical assistant concerning a 69 year old female with hyperthyroidism, hyperlipidaemia, hypertension and no history of drug reactions/allergies who on 15-MAR-2007 was vaccinated with one dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM.  Concomitant therapy included aspirin, simvastatin (MSD), DIOVAN, and atenolol.  On 16-MAR-2007, the patient experienced redness and swelling from the shoulder to elbow in the arm in which she was vaccinated.  Medical attention was sought.  Treatment included topical hydrocortisone and TYLENOL.  At the time of reporting, the patient had recovered.  Additional information has been requested.
Shingles (Herpes zoster) noted approx 80 hrs after flu vaccine
I didn?t notice it until a day or two after my vaccine, but I developed a rash all over my face and at my injection site. My skin was covered in teeny, tiny bumps, my face was red all over, and I was mildly itchy. I gave it a couple of days to see if it lessened, and then I contacted my doctor. They told me to take Benadryl at night for a few days. This helped the bumps smooth out, but my skin  was still covered in red marks where each bump had been. I continued the Benadryl for a couple of weeks and also tried Benadryl and hydrocortisone cremes. After a month, my skin was smooth, the correct color, and only had a few red marks on either cheek. At this point I stopped treatments beyond my regular Zyrtec and aloe Vera. About 10-12 days later, I noticed the raised, itchy, red bumps were coming back on my face (but not on my arm). It did not come back as strongly as before, but it was obviously back. I contacted my doctor again, who told me to use hydrocortisone crème twice a day for 3-4 weeks and if it is still not gone, I will be referred to a dermatologist.
lots of stiffness on the right arm; unable to move the neck towards left side; pain at left arm near shoulder at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (lots of stiffness on the right arm), NUCHAL RIGIDITY (unable to move the neck towards left side) and VACCINATION SITE PAIN (pain at left arm near shoulder at injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024B21A and 015M30A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included BENAZEPRIL for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID], FOLIC ACID, VITAMINS NOS, LEVOTHYROXINE, DOXAZOSIN MESILATE (DOXAZOCIN), HYDROXYCHLOROQUINE, PREDNISONE and ADALIMUMAB (HUMIRA) for an unknown indication.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at left arm near shoulder at injection site). On 28-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (lots of stiffness on the right arm) and NUCHAL RIGIDITY (unable to move the neck towards left side). At the time of the report, MUSCULOSKELETAL STIFFNESS (lots of stiffness on the right arm), NUCHAL RIGIDITY (unable to move the neck towards left side) and VACCINATION SITE PAIN (pain at left arm near shoulder at injection site) outcome was unknown.            concomitant medications included OTC  medications.  treatment information was not provided.   This case was linked to MOD-2021-258008 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 contains non significant information
fever; chills; arthritic-like pain moving from joint to joint; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non health care professional..  This case involves a 66 years old male patient who experienced fever (PT: Pyrexia), chills (PT: Chills) and arthritic-like pain moving from joint to joint (PT: Arthralgia), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Fluzone high dose).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  On 04-Sep-2019, the patient received a dose  of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious fever (PT: pyrexia), chills (PT: chills ),   arthritic-like pain moving from joint to joint (PT: arthralgia) (about 3 days) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests included no lab data. Final diagnosis was arthritic-like pain moving from joint to joint, chills and fever.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for pyrexia, chills and arthralgia.  Information on batch number is requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 40-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 19-Nov-2015 and Miscarriage on 15-Jun-2020. Concurrent medical conditions included Vegetable allergy (Allergic to tomatoes), Pollen allergy (tree pollen), Allergy to molds, Drug allergy (Allergic to Advil/Aleve), Seasonal allergy (Gotten better over the pandemic), Migraine and Acid reflux (esophageal). Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) from January 2020 to an unknown date for Acid reflux (esophageal), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 2014 to an unknown date for Pregnancy, PROBIOTICS NOS from 2014 to an unknown date for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 19-Jun-2021. On 11-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 11-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she had grandparents who have had heart attacks, stroke, and Alzheimer's.   On 20-Nov-2020, lab test also included genetic test; however, the result was normal. Patient's estimated date of conception was on 26-Sep-2020. Number of fetus was found to be one. Previous pregnancies reported on 19-Nov-2015 with live full-term birth without complication and miscarriage on 15-Jun-2020.  Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 40-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Headache, Chills, Hot Flashes, Fatigue, Nauseous, Muscle and joint pain.  No Fever.  These symptoms have continued with no improvement for approx  20 hours since injection.
Rash, body gets very hot, like hot flash, sparked  migraine headache, sore arm, tired/sleepy
severe case of COVID/chills/shivers; received his third; Lack of efficacy; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (severe case of COVID/chills/shivers) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 011M20A and 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vasculitis (Presumed to be giant cell arteritis but not seen in biopsy.) and Steroid therapy since 2013. Concomitant products included PREDNISONE for Vasculitis, DULAGLUTIDE (TRULICITY), ISOPHANE INSULIN (NPH INSULIN) and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced COVID-19 (severe case of COVID/chills/shivers) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of efficacy). On 17-Aug-2021, the patient experienced OFF LABEL USE (received his third). The patient was hospitalized on 28-Jul-2021 due to COVID-19. At the time of the report, COVID-19 (severe case of COVID/chills/shivers), DRUG INEFFECTIVE (Lack of efficacy) and OFF LABEL USE (received his third) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  Patient was on unspecified regular insulin. The patient received a booster (third dose of the product), which had been captured as off label use; after, the reported event of COVID-19. So, the third dose of product was not suspect for the event lack of drug effect.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded. The patient received a third dose of the product, which was captured as off-label use.    This case was linked to MOD-2021-294409 (Patient Link).; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded. The patient received a third dose of the product, which was captured as off-label use. Further information has been requested.
She got her vaccine,  had no reaction at all.  Starting today she lost her sense of smell, also having a headache.   She also has a runny nose, shortness of breath and nausea.  She has not taken anything for these symptoms.  She called her PCP and they have called her in a prescription for Phenergan.
asymptomatic sebaceous cyst over mid-sternum present for over 20 years became infected; This is a spontaneous report from a contactable nurse (patient herself).   A 72-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6200, Expiration date: unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 (age at vaccination: 72 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included arthritis (osteo/psoriatic), silent reflux, psoriasis and asymptomatic sebaceous cyst over mid-sternum present for over 20 years became infected. Concomitant medication(s) included apremilast (OTEZLA); dexlansoprazole (DEXILANT); ubidecarenone (COQ10) and multiple vitamins, all taken for unspecified indication start and stop date were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201) via unknown route in the left arm on 13Feb2021 18:00 (age at vaccination: 72 years) as DOSE 1, SINGLE for covid-19 immunisation. On 21Mar2021 03:00 (after 2 weeks), the patient's asymptomatic sebaceous cyst over mid-sternum present for over 20 years became infected. Allergies to medications, food, or other productswas  unknown. The patient had incision for drainage and antibiotics as treatment for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events caused the patient for doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for coivd-19 since the vaccination. The outcome of the event was recovering.  Follow-up attempts are needed. Further information is requested.
Headache, muscle aches (full body), nausea, vomiting, fever (99-101), chills 30 hours Feb. 17, 2023; 10 p.m. to Feb. 19, 2023; 7 a.m.
had new onset seizure 24 hours after administration of Moderna Bivalent booster at pharmacy.  Seen at ER and had negative work up including CT head, EKG, labs.   Seen at PCP office in follow up and being sent for evaluation with neurologist, further labs, and MRI brain.
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M040269, expiration date on 28-APR-2018 (Strength, dose number and anatomical location were not provided). No adverse effects were reported. It was stated that the vaccine was exposed to a temperature of 48°F (Fahrenheit degrees) with a time frame of 10 minutes. It was stated that the temperature excursion was noticed due to a data logger. No previous excursions were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA002375.
RECEIVED PFIZER AS FIRST DOSE COVID VACCINE 2/6/2021. RECEIVED MODERNA AS SECOND DOSE ON 4/2/2021.
Within 24 hours, developed fever, body aches, and fatigue; resolved after one day. Two weeks later developed severe fatigue, tinnitus, exercise intolerance, and joint pain which has continued to this day. Recently developed tingling in upper extremities. Diagnosed with fibromyalgia.
Patient brought back to clinic 2 weeks post vaccination with induration and erythema to Right thigh.  Mother states both thighs were red two hours after vaccination and right thigh developed swelling with fluid.  States also that sore drained spontaneously.  Warm compress to site ordered.
Sever rash up and down front of leg, both legs especially at ankles.  APRIL 12 STILL red and presented itself MARCH 30.  10-12 days after 2nd shot
Severe muscle pain in arm where injection was given. Pain started within two hours of injection. I could barely move my arm several hours later. The pain was severe where I couldnt' sleep without taking pain pills for the pain.  The pain radiated across my neck. The injection site pain lasted three days. My shoulder joint began cracking the next day and has cracked the third day after the injection. Prior to the injection, I had no muscle pain in my arm nor did I have any shoulder joint cracking. The injection was painful.
Sore between the neck and the shoulder; Warm to touch in the injection site; Redness in the injection site; Swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore between the neck and the shoulder), VACCINATION SITE WARMTH (Warm to touch in the injection site), VACCINATION SITE ERYTHEMA (Redness in the injection site) and VACCINATION SITE SWELLING (Swelling in the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, the patient experienced NECK PAIN (Sore between the neck and the shoulder), VACCINATION SITE WARMTH (Warm to touch in the injection site), VACCINATION SITE ERYTHEMA (Redness in the injection site) and VACCINATION SITE SWELLING (Swelling in the injection site). At the time of the report, NECK PAIN (Sore between the neck and the shoulder), VACCINATION SITE WARMTH (Warm to touch in the injection site), VACCINATION SITE ERYTHEMA (Redness in the injection site) and VACCINATION SITE SWELLING (Swelling in the injection site) outcome was unknown.            Concomitant included Losar pen for blood pressure. Treatment information was not provided.
Post vaccine pt developed dizziness, nausea and became sweaty. Pt transferred via wc and arrived to obs at 0905. Vitals obtained and monitored. Symptoms resolved. Per physician, pt experienced classic non syncopal vasovagal reaction - resolved. Pt released to home by self at 0920. Vitals as follows: 0909 Lying BP 123/83 HR 67 RR 20 SPo2 96 0915 Sitting BP 134/84 HR 67 RR 18 SpO2 99 0916 Standing BP 119/83 HR 70 RR 18 SpO2 98
Pain in extremity; erythema; edema peripheral Information has been received from a licensed practical nurse concerning a 53 year old white female with a tetanus allergy and clindamycin allergy, who on 25-OCT-2005 was vaccinated IM into the right arm with a fifth dose of pneumococcal 23v polysaccharide vaccine (lot #651526/0604R). Concomitant therapy given IM into the left arm included a second dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (influenza virus whole virion 3v vaccine inactivated (lot #U1777AA) montelukast sodium (MSD) calcium (unspecified) (+) vitamins (unspecified) and temazepam (Restoril). There was no illness at the time of vaccination. On the evening of 25-OCT-2005 the patient's upper arm became extremely painful, red and swollen. The patient's arm remained painful and swollen for 4 to 5 days. Unspecified medical attention was sought. The patient was treated with ibuprofen and acetaminophen (Tylenol) for the discomfort. It was noted that the patient started to feed better after 7 days. On 01-NOV-2005 the patient recovered. An investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been check by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
PATIENT WAS GIVE DOSE OF 0.5ML INSTEAD OF 0.3ML, AROUND 8PM THAT EVENING, PATIENT CONTACTED US STATING THAT HE FEELS DIZZY AND TIRED
Mom reported with last set of vaccines developed hives-given Benadryl ~ 24 hrs post vaccines and subsequently worsened with resp distress and apnea-also possibly with seizure activity-nonresponsive with eyes rolled back-EMS called. Lasted ~ 5 to 10 minutes with (+) cyanosis.