chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had nausea, vomiting and diarrhea after receiving the vaccine. He also reported coughing and difficulty breathing, "chest pressure" as well as shaking. He visited ER x-ray did not show any infection.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant medication was not reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
10/05/2001 Fever for 24 hours after 2 month vaccines. 12/02/2001 admitted 48 hours after 4 month vaccine with T 104 and suspected encephalitis.
Woke up with extreme pain in my left shoulder, unable to use that arm, felt shaky ans sick to my stomach.  Went to my Dr after about 2 weeks with the shoulder still swollen, quite painful and range of motion still limited.  Started anti inflammatory med and physical therapy, returned in August still having pain and motion problems, had an MRI noting severe bursitis and a tear in the shoulder.  Was given a steroid shot that helped, but the shoulder is still painful and I have been told there is an impingement.
Vials were administered to several patients after 4-5 days past the 30-day storage mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials were administered to several patients after 4-5 days past the 30-day storage mark) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials were administered to several patients after 4-5 days past the 30-day storage mark). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials were administered to several patients after 4-5 days past the 30-day storage mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: No significant information was received.
Information has received from a medical assistant referring to a 12 years old female patient. The patient had no medical history or drug reactions/allergies. There was no concomitant medication. On 29-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K011492, dose and expiration were not reported). The patient was seen in the office on 05-DEC-2014 due to the patient developing migraines on an unspecified date. The patient was prescribed IMITREX as treatment on 05-DEC-2014. The patient then received the 2nd dose of GARDASIL (Lot# was reported as L011846 and exp. 06-JUN-2017, dose was not reported) on 06-JAN-2015. The patient was seen in the office on 22-JAN-2015 due to the patient developing body aches, nausea, dizziness and "the IMITREX wasn't helping" (unspecified date). The medical assistant stated the patient was switched from IMITREX to TOPAMAX on 22-JAN-2015 as treatment for the symptoms that were not reported on 22-JAN-2015. The patient then received the 3rd dose of GARDASIL (Lot# K008931 and unspecified expiration date, dose was not reported) on 04-FEB-2015 (Inappropriate schedule of vaccine administered) and then received a 4th dose of GARDASIL 9 (Lot# L016429 and unspecified expiration date, dose was not reported) on 02-NOV-2015 per patient's mother's request (Extra dose administered). The patient's mother called the office on 03-FEB-2016 stating the patient was experiencing headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision (all which started on an unspecified date) and had missed an unspecified number of days of school (unspecified dates). The patient was referred to an unspecified neurologist and had a CT scan of the head, brain and spine performed (unspecified date) which came back as "normal". The outcome of the events was unknown. Causality was not reported. The reporter considered the event of headaches, dizziness, "severe" pain in the head, neck, arms and legs, blurry vision to be disability as the patient hadn't been able to attend school. Additional information has been requested.
Information has been received from a pharmacist via a company representative referring to unspecified number of patients of unknown age and gender. On an unknown date these patients were vaccinated with PNEUMOVAX23 (dose, frequency and lot# were not reported). After vaccination, on an unknown date, the patients experienced injection site reactions which were pretty severe. The outcome of injection site reaction was unknown. The relationship between the event and PNEUMOVAX23 was not reported. It was unspecified whether these patients sought medical attention or not. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
Started feeling poorly yesterday.. thought it was allergies.  I woke up this morning feeling absolutely terrible.. had a 102 fever, chills, body aches, headache, sore throat, cough, trouble breathing. This evening I?ve had nausea, vomiting, diarrhea, along with above listed.  I was told by a nurse to report this breakthrough infection to VAERS.
fever of 100.5; severe muscle and joint aches for about 24 hours; severe muscle and joint aches for about 24 hours; severe headache; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: E11283), via an unspecified route of administration on 07Jan2021 06:30 at a single dose for covid-19 immunization. The patient's medical history included osteoarthritis from an unknown date and unknown if ongoing. Concomitant medication included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]), famotidine (FAMOTIDINE), hydroxychloroquine (HYDROXYCHLOROQUINE), escitalopram oxalate (LEXAPRO), rosuvastatin calcium (ROSUVAST) , cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took cipro [ciprofloxacin hydrochloride monohydrate] and experienced drug hypersensitivity, vioxx and experienced drug hypersensitivity, ees and experienced drug hypersensitivity. On 07Jan2021 at 18:30, 12 hours after the injection, the patient experienced fever of 100.5 with severe muscle and joint aches for about 24 hours. Then the fever subsided and had severe headache for 24 hours. All the events recovered in Jan2021.
This spontaneous report was received on 06-MAR-2017 from a receptionist at physician's office and refers to an unspecified 12 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. The receptionist reported that the patient mistakenly received a dose of PROQUAD injection (exact dose, route of administration, lot # and expiry date were not reported) instead of M-M-R II injection. No adverse effect reported. No additional information was provided. Product quality complaint was not involved. Demographic information incomplete due to receptionist disconnecting before getting information. Additional information has been requested.
I had shingles appear on the left trunk of my body and was prescribed Valtrex by my health care provider.   I have taken the medication for the past eight days and symptoms have greatly improved and currently mild.
Left arm where shot given extremely sore, around 1845 started chilling, then felt freezing cold inside and burning hot outside lasting around 0900  the next morning.
This spontaneous report as received from a licensed vocational nurse refers to a 13 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 25-AUG-2015 at 04:14 pm, the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX injection, lot # L010145, subcutaneously (dose and expiration date were not provided) that was improperly stored. Other suspect therapies included MENACTRA, Hep A vaccine (unspecified) (manufacturer reported as GlaxoSmithKline) and Tdap (manufacturer reported as Sanofi) (all administered on the same day and time, intramuscularly). This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
cried; This is a spontaneous report from a contactable nurse. A 4-month-old male patient received the second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot no: W62465, expiration date: 31Jul2020), administered intramuscularly on right thigh on 21Mar2019 at 0.5 ml, single for routine vaccination in physician's office. The patient's medical history was not reported. Concomitant medications included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) intramuscular on patient's left thigh, hib vaccine conj (ompc) (PEDVAXHIB) intramuscular on right thigh, and rotavirus vaccine live reassort oral 5v (ROTATEQ) oral, all administered in the physician's office on 21Mar2019 for immunization. The patient previously received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 10Jan2019 for immunization. The nurse reported that the patient was administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and the solution leaked out of the hub during administration on 21Mar2019. The nurse further stated that the solution leaked out of the hub during administration. Seriousness criteria verified as not serious, the nurse provided that there were no adverse events that occurred related to this event, he just cried. The first administration of this vaccine was on 10Jan2019. Therapy was ongoing because product was prescribed as a series of vaccinations. On 21Mar2019, administration was stopped during administration and a second dose of 0.5mL intramuscular injection to right thigh administered in response to this event. The patient was scheduled for additional administration in the future as part of routine vaccination series; this schedule has not been changed. Outcome of the event "cried" was unknown.
Very sore left arm 2 days after administration of vaccine; moderate swelling of upper L arm with limited range of motion due to soreness; deltoid muscle was hard. 3 days after administration, patient presented to walk-in clinic for treatment & was given Benadryl & Medrol Dosepak. 3 days later, symptoms were improving. Localized reaction. Missed six days of work.
It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks; This spontaneous case was reported by a patient and describes the occurrence of RASH (It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Psoriasis. Concomitant products included VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN D3 and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks). At the time of the report, RASH (It just started with just patches of bumps on my elbows / rashes on his back, elbow, ankles, private parts, and even his buttocks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had been taking Vitamin pills (Vitamin D3, C, Zinc) before the Covid shots and psoriasis completely disappeared. Further it was reported that It was just started with just patches of bumps on patient's elbows. There was no itching.  Further in the follow up it was it was reported that the patient had a couple of patches on body before patient got the shot, approximately 3 years ago. When COVID came about patient started taking Vitamin D and other vitamins which helped get rid of psoriasis. However, after receiving shots of the Moderna COVID-19 patient started getting rashes again. Patient had rashes on back, elbow, ankles, private parts, and even buttocks.  No treatment medication was provided by the reporter.   This case was linked to MOD-2022-674385 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Follow up received included significant information, secondary reported, as reported event verbatim and narrative was updated.
feel bad; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer via media.  This case involves patient (unknown demographics) who experienced feel bad (feeling abnormal) after he/she received INFLUENZA VACCINE.  The patient didn't report of any medical history, concomitant disease or risk factor.  Medical treatment, vaccination and family history were not provided.  Concomitant medication included OSELTAMIVIR PHOSPHATE (FLUCLE).  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that this case was received via media. It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results reported..  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.   There will be no information on batch number for this case.
Severe body aches in neck, shoulders and back-unable to sleep because of the pain Unable to regulate body temperature/felt very cold Malaise General feeling of being quite unwell
Urticarial rash right thigh centered on injection site, nearly 8cm x 8.5 cm. Resembling erythema. Migraine. Rx with Benadryl po.
was kneeling on floor playing w/his food when head jerked & rt arm & head shook for 20 sec; pt then started playing w/food w/jabbering; pt went to bed early;
Case was hospitalized and passed away.      **2nd dose given 2/6/2021.
local reaction L arm deltoid area 4 1/4" x 4 1/4" oval/round indurated area. Non tender but red blanching
Moderna COVID-19 Vaccine EUA I woke up to severe chills, a fever and a headache at about 1:30 in the morning. I couldn't even get out of bed to take any medicine until about 4:00 am when I finally took 2 ibuprofen and slept until about 9.  I took more ibuprofen throughout the day. The only side effect I had the rest of the day and part of the next day is fatigue.
This spontaneous report was received from a registered nurse refers to some patients (also reported as female) of unknown demographics. On an unknown date the patients were vaccinated with doses of GARDASIL (lot#, expiration date and route not reported) after an interruption in the GARDASIL vaccination schedule. On an unknown date the patients complained of "burning and that the injection site hurts". The outcome of the events were unknown. The patients sought medical attention as these events happened in the office. Causality was not reported. This is one of the two reports from the same source. Additional information has been requested.
RN asked the patient to confirm that it's her second covid booster. Patient said that it's her second booster. RN checked the patient's vaccination card and didn't see any documentation for her second covid booster. RN gave the patient her covid shot. RN checked and saw that patient received her second booster on 06/15/22. Patient called Private to confirm if she received her second booster. Nurse confirmed that she received it on 06/15/22. Patient didn't feel any adverse reaction from the Covid vaccine. Patient said she feels fine.
arm was sore; high fever at 100 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and PYREXIA (high fever at 100 degrees) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and PYREXIA (high fever at 100 degrees). At the time of the report, PAIN IN EXTREMITY (arm was sore) and PYREXIA (high fever at 100 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 100 degrees (High) High fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "known allergies: Penecillan" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in lower legs, severely nauseous.  Have had no energy since, always tired, muscles always ache.  Very low blood pressure since.  Depression and joint pain, especially in the knees.
death Acute renal failure, unspecified acute renal failure type (CMS/HCC)
Pfizer Covid-19 Orange top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg
pain in rt deltoid post immun when exercises vigorously or scrubs vigorously causes pain;pt does not feel nodule or lumps;uncomfortable to sleep on it;
Caregiver received first Pfizer dose and immediately started to feel bad. Started having racing heart, nausea, abdominal pain, shaky and "pins and needles feeling." CG vitals taken, HR noted to be in 1-teens but reduced to 80s shortly after, BP was 120/80, O2 sat 99%. CG stayed for 1 hour post vaccine and states her symptoms resolved. Today just has a sore arm and a little nausea.
IMMUNITY IS WANING; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced immunity is waning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immunity is waning was not reported. This report was non-serious.
Fever, lethargy resulting in unconsciousness. Diagnosis of Acute Dissemination Encephalomyelitis. Treatment of steroids and IVIG needed along with inpatient and outpatient therapy.
Daily Hives, sometimes on legs, sometimes arms, sometimes full body., Angiodema of Lips Occasionally - Visited local Hospital ER  several times-prescribed Steroids-IV Benadryl & Pepcid, Visited alternate Hospital once-Complete Blood Panel-prescribed steroids- Treated since November 2021 at Allergy & Asthma facility- Prescribed Singulair, 4X Over Counter Allegra and Zyrtec, 2X Pepcid daily, also Hydroxizine nightly.  As of today (02.03.23) still experience daily hives.
Convulsion for 40 mins then went to ER. Admitted to the hospital. Diagnosed with infantile spasm. *F/UP report on 3/25/03: Continues on meds for infentile spasms.*