chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) and described the occurrence of nausea in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, within months of vaccination with FLULAVAL, the subject experienced nausea, syncope and flushing. At the time of reporting the outcome of the events were unspecified. The healthcare professional reported another case with FLULAVAL. See case A1043122A for details on the other case.
Pt scheduled for 2nd Booster (4th in series) Moderna given instead of Pfizer
24hrs post immunization- felt dizzy all day  48hrs post immunization -3/4 underarm frontial cellulitis right deltoid around bicep  -had lymphodema in axillary area that turned into ecchymosis down to the mid breast lateral area -used NSAID, heating pads
Patient began to experience heavy menstrual bleeding 10 days after vaccine and petechie 28 days after with subsequent platelets of 2 on admission to hospital
was sick; achy; broke out in blisters; broke out in rash on arms; high temperatures; teeth chattering; something in my throat; swelling in throat; I couldn't breathe; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking) and ILLNESS (was sick) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038821A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ALPRAZOLAM (XANAX) for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking) and CHILLS (teeth chattering). On 16-May-2021, the patient experienced ILLNESS (was sick), PAIN (achy), BLISTER (broke out in blisters), RASH (broke out in rash on arms) and PYREXIA (high temperatures). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (something in my throat), PHARYNGEAL SWELLING (swelling in throat), DYSPNOEA (I couldn't breathe), TREMOR (shaking), ILLNESS (was sick), PAIN (achy), BLISTER (broke out in blisters), RASH (broke out in rash on arms), CHILLS (teeth chattering) and PYREXIA (high temperatures) had resolved.            Additional concomitant product used included Lortab (generic), 1 a day.  This patient was treated by EMS (Emergency Medical Services) and transferred to the hospital. While at the ER (Emergency Room), she was treated with steroid shots NOS, epi pen, adrenaline, diphenhydramine (Benadryl) and IVs and sent home. The next day on 16-May-2021, she broke out in blisters that were the size of the end of a pen that you push.  Treatment provided included Tylenol (paracetamol), Benadryl, steroid shots NOS, Epi Pen, adrenaline and IV NOS.
Dr stated patient Had a "Vasovagal Syncope Episode" Patient was Pale, and clammy. Patient stated he couldn't see for roughly 15 minutes. Dr had me bring patient by wheelchair to exam room, had him lay on stretcher & propped his feet up. After about 20 minutes. Patient stated he felt better, then Dr  discharged him. Parent drove him home.
4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022; No adverse event; 4 patients were administered with doses BUD on 23Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023), PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023), PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023) and PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022).    No concomitant medications were reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was reported.
pain in left arm, numbness. Then developed a itchy rash and a lump in the cubital fossa and swollen lymph nodes. Initially took benadryl, then went to the ED. An ultra sound showed a clot located in her left cubital fossa. Transferred to Med center started on eliquis and released from the hospital. Now complaining of pain in the left leg. Adv caller to follow up with her pcp about the pain.
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. On 15-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # H012643 and expiry date: 30-MAR-2015). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Shoulder pain, arm pit pain, deep scapula pain with inability to move arm without significant pain starting on 12/20.
Several minutes after immunization, patient reported feeling dizzy, then lost consciousness for approximately 5 to 10 seconds. He remained upright with assistance the entire time.  Approximately 5 minutes after regaining consciousness, he vomited.  He was given a wet cloth for his face and recovered quickly.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed in VAOS is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA) (modernatx.com). Patient contacted on 12/4/2021 and no adverse effects reported.
Pt called office on 12/11 to report she received ZOSTAVAX at pharmacy on 12/9. Noted red, swollen area at site on 12/10 PM. Advised cool compresses & Ibuprofen. In office 12/13 with with family site noted added CLARITIN or BENADRYL to Rx. Also reported that she received flu shot in same arm on same day.
splitting migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (splitting migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 7:00 AM, the patient experienced MIGRAINE (splitting migraine). The patient was treated with NAPROXEN SODIUM at an unspecified dose and frequency. At the time of the report, MIGRAINE (splitting migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 341240) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant information was not provided.
This spontaneous report was received from a medical assistant refers to unspecified 13 patient of unknown age and gender. This report pertains to 2 patients who on 18-JUL-2013 were vaccinated with VARIVAX, (lot # H014074, expiry date 20-JUL-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX that was exposed to unsupported temperature conditions were administered to 2 unspecified patients. No adverse effect reported. No further information was available. This case is linked to 131USA007815, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009870, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875, 1312USA009869 (Same reporter link). Additional information has been requested.
Information has been received from a registered nurse (R.N.), for the Pregnancy Registry for GARDASIL, concerning a 22 year old female who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL (first lot #0151X, second lot #0250X) on 28-APR-2008 and 30-JUN-2008, respectively. The patient had 3 previous pregnancies and 2 elective terminations. Subsequently, the patient discovered that she was pregnant. Her LMP was 15-JUN-2008. On 03-SEP-2008, she had ultrasound and "the results were normal and she was 12 weeks gestation at that time". On 13-OCT-2008, she had serum alpha-fetoprotein test and the result was normal. No adverse effects reported. The patient sought medical attention via office visit. Additional information was received from a physician via Initial Pregnancy Questionnaire. The physician reported the patient had 3 previous pregnancies and 2 elective terminations. The patient's LMP was 15-JUN-2008 and estimated delivery date was 02-MAR-2009. The result of patient's serum alpha-fetoprotein test was normal on 13-OCT-2008. Follow up information was received via pregnancy questionnaire indicated that the patient delivered a normal male baby on 05-MAR-2009, 38-39 weeks from the patient's LMP, weighting 9.1, length 21 inches. There was no congenital anomalies, complication, infections or illnesses during pregnancy and no complication during labor/delivery. It was also noted that the patient took VITAFOL during this pregnancy. Follow up information was received which reported the patient with G3P0 on 05-MAR-2009 underwent C-section. The baby was well health. Upon internal review, the C-section was determined to be an other important medical event. Additional information is not expected.
edema in left and right feet, increased pain and loss of use of all fingers of both hands, anemia,
While driving home from the hospital about 50 minutes after the shot, I got SOB, hot flashes, dizzy and almost lost consciousness.  My heart rate showed 157.  I felt disoriented and was having trouble mentating/finding words when Speaking with the 911 operator and the EMS staff.
On 05/03/2021, client called with c/o "big red welps on arms, legs and stomach that are itching" states has taken benedryl but not working. Denies any difficulty breathing or swelling. Had Covid-19 vaccine on 05/03/2021 and 2 hours later the hives appeared. Instructed needs to see PCP since hives are widespread. Verbalizes understanding states will call and make appt..   05/05/2021 Tried to call patient but had to leave voicemail.
On day of immunization, patient experienced more pronounced soreness in arm receiving injection than expected. Two days later she noticed small area of bruising at injection site and an area of redness and swelling about 4 inches below injection site that is approximately 4 inches wide by 3 inches high. She reports that she also has trouble lifting said arm above her waist.
5 inch swelling around the site of injection, muscle and joint pain, restless sleep, hives, body aches. Lasted 4 days.
Immediately after injection completed, patient complained of dizziness and was noticeably pale, but did not pass out. Pt instructed to remain in seat and that there was no rush. Per patient request, water given. Initial blood pressure reading of 80/52 and 55 BPM. Per patient, she expressed familiarity with "vagal" response and that her blood pressure often runs low. Per patient, had dizziness in past to flu shot but not as worse as current event. After ~10-15 minutes, patient expressed that she was feeling better and was ok with leaving. Patient instructed to report to clinic if symptoms continue or if worsen.
Caller mentions that she had no side effects from the vaccines, other than her arm being sore.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06May2021 (Lot number: EW0169) as dose 2, single and administration date 15Apr2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Caller mentions that she had no side effects from the vaccines, other than her arm being sore.".  Additional information: Reporter states that she was calling about the Pfizer Product:  Covid 19 Vaccine.  Weight:  Reported by the caller as 140-145 pounds. Reporter denies any other medications, medical conditions, labs, testing or treatments relevant to report. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine: None. No AE(s) following prior vaccinations. Patient had no medical History (including any illness at time of vaccination). Family Medical History Relevant to AE(s): Not Provided. Relevant Tests: None  Follow-up attempts completed. No further information expected.
Reaction on left side of lip and tongue-swollen.  Rash (hives/itching) at injection site on left arm.  Sore for 7 days.
2 days post vax, the child broke out in large red welts and hives on face, neck, trunk and arms, legs and back. Seen by MD and was instructed to give Benadryl every 4-6 hours. The pt also experienced slight occasional itching.
injection site pain, body aches, fatigue, fever of 104 by midnight, crying, chills, severe arm pain, complaints of shock like shooting pains in hands and feet, flushed red skin, nausea, pain on deep breath, sleeping for hours.  treated with ibuprofen 400 to 600 mg every 4-6 hours.
Red, hive-like rash started on arm around vaccine site and spread to chest/arms/buttocks. Used Benadryl, resolved 48 hrs.
red and swollen and HOT around injection site.  Was itchy but that passed.  Have a slight fever...
Sharp pain left eye; pain to left eye/swelling; This is a spontaneous report from a contactable consumer(patient). A 65-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Not reported) via an intramuscular route of administration, administered in Arm Right on 18Feb2021 at 16:00 as (age at vaccination 65-year-old) dose 2, single for covid-19 immunization. The patients medical history was not reported. The patients concomitant medications were none. Historical vaccination included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: Not reported) via an unspecified route of administration, administered on an unknown date (age at vaccination 65-year-old) as dose 1, single for covid-19 immunization and experienced very weak and fatigued. No vaccine was administered within 4 weeks Prior to vaccination. The patients medical history and concomitant medications was not reported. On 20Feb2021 at 19:00 the patient experienced sharp pain left eye, pain to left eye/swelling. The patient visited physician office for the events.  Antibiotics was given as a medication for the events. The outcome of the events was reported as recovered on 30Mar2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pale, red, eyes swollen, skin on face hot. Received FLUMIST on Sept 21, 2011 on or about 0900. No problems after mist was given. Noticed on or about 0500 next morning the symptoms listed above.
Sudden painful, almost paralyzing,  Heart Attack - Coronary Artery Disease, Drug eluding Stent in Left Anterior ( Widow-Maker ) descending artery Sudden Onset when on my second or third lap swimming in the daily Swimming program the morning of Wed, Oct 13, 2021. Was on a course of Prednisone for a Back injury suffered the week before. I thought I was having a bad case of Angina/Chest Pain since I had a similar (NOT Heart Attack ) documented event in 2013. I managed to get myself home and take the prescribed Prednisone hoping that would give me relief...but it did NOT.  Had son take me to ER who then transferred me the the Medical Center.
On Fri, 10/08, she began to feel poorly & had one episode of diarrhea which was followed by constant but transient pain and progressed to muscle weakness and double vision. She was admitted to hospital on 10/12/10 with Dx. Guillain-Barre. She was placed on ventilator for awhile and was receiving therapy before discharge on 11/18/10. She continues with therapy & is now able to speak, eat and amb with assist of walker. On Sept, 9th she was ill with 102 degrees fever. On Sept, 11th she saw the dr for low-grade fever and a rash on her LE's. She was placed on ATB. Additional information which may or may not be related.
Headache, muscle aches, fever of 101, chills, nausea, fatigue.
Pt presented with respiratory failure, mechanical ventilator, oxygen dependent, left torticollis, dysphagia, right diaphragm paralysis, right sided hemiparesis, swelling at right hemi cord - medulla oblongata through C6. NG tubes, feeding tube dependent. Pt was diagnosed with transverse myelitis. Pt treated with IVIG, steriods and antibiotics
Patient got the Vaccination around 5pm on 10/15/20. Patient said arm was sore, but didn't look at it until she got home around 6pm. Noticed it was red and swollen. Patient awoke 10/16/20 with red area growth, painful and swelling in the area. She went to MD, who ruled it as a bacterial infection due to injection site reaction.
Patient received a flu vaccine on 2/22/18 and 3/22/18 because she had only received one dose in the previous season. She returned to clinic on 4/25/18 and received a 3rd flu vaccine in the same season that was not necessary.
My symptoms did not start for months. I got the vaccine in March and the symptoms started in mid June. I went to the foot Doctor, they used a machine on the foot to relieve the pressure and pain. I continued with exercise regime to help my back and wore a brace for two weeks.
Paresthesia, Pain in Limb, Foot Arm and Hand,chronic inflammatory demyelinating polyneuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 17-JUL-2009, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered numbness in legs and hands, trouble walking, balance issues, pain in the left hip that radiated to the left leg, pain in fingers of right hand, and motor weakness. The pt was diagnosed with paresthesia, pain in limb, foot, arm and hand, and chronic inflammatory demyelinating polyneuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was unknown. Causality assessment was related.  The reporter considered the event to be disability. Upon internal review, chronic inflammatory demyelinating polyneuropathy was considered to be medically significant.
Facial numbness started at my left lip and going into my check and now forehead.  Less smile on left side lip. Bumpy rash on both cheeks
This spontaneous report as received from a pharmacist refers to a 32 year old male patient. On 15-MAR-2014, the 32 years old patient was vaccinated with his first dose of GARDASIL lot # K007360, expiration date: 02-FEB-2017, 0.5 ml, intramuscular. On 23-MAY-2014, the patient received second dose of GARDASIL and on 19-OCT-2014, 7 months after his first dose, he received third dose of GARDASIL, both lot # K007360, expiration date: 02-FEB-2017, 0.5 ml, intramuscular. No adverse effects were noted by the patient. The patient did not seek medical attention. Additional information has been requested.
Itching on legs, red blotchy rash traveled from legs to trunk to arms. No other symptom.