chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heavy bleeding, hemorrhaging, passing large blood clots, passing out, soreness, head aches, high blood pressure, low blood pressure, fever, chills, skin discoloration, nose bleeds, heart apnea, tachycardia, uti blood transfusion estrogen shots, anemia, sweats, room was 40 degrees and she was having hot flashes, dizziness, hit head twice as a result of passing out, no appetite.
She got her vaccines both in the left arm, immediately she screamed when she got it, the pharmacist noticed it as it was very painful.  Then he told her to sit down and after a few minutes she left to go home.  He told her to take an apirin and to take another Tylenol which she did.  For the next few days she had to lie down every afternoon as she could not stay awake and she slept.  Then a breathing problem began, went back to the pharmacy and asked what the side effects of the vaccine were and they gave it to her.  She called her family doctor and told them what happened as her doctor recommended for her to get the vaccine.  She noticed increasing difficulty breathing when she was active.  If she is sitting down doing nothing then her breathing seems to be OK.  When exerting herself, and going outside and starting to breath now it is more labored than it was before, and it got bad.  She told her doctor that it was better, but she had not been moving around for 2-3 days.  When she went outside her breathing problems got worse.  The PCP told her to go to the ER if she got worse, and on Saturday she went to the ER after 3 weeks.  In the ER they did all kinds of tests, and a nurse had to walk around with her and they were testing her, did x-rays of her chest, blood work, and they checked her oxygen intake as perhaps she may have had a blood clot in her lungs.  She said all they walked was a few steps and they saw first hand that she was having problems breathing, and was admitted to the hospital.  They did a CAT scan and gave her a nebulizer.  The nebulizer did help her.  The next morning before noon they did release her saying that her symptoms could have been related to allergy from RSV vaccine which may have triggered her asthma.  Flu and COVID testing was negative.   She was diagnosed prior with allergic bronchitis and has not had any inhalers for 6 years, and never had a history of asthma itself.  Her regular reaction was itchy eyes and itchy nose and no breathing issues, or if she did they were not as bad as they are now.  She was discharged home with nebulizers, and her breathing is better.  She told her PCP that her legs felt like lead and had difficulty walking as she was so out of breath that they felt like lead.   If she walks around she may difficulty breathing again and is supposed to go to therapy.  She feels that she may be stuck with these symptoms.  She tore her right tendon in her shoulder and that's why she is going to go to therapy for that.    Her breathing was normal prior to the vaccine, and she is now having difficulty breathing, and you can tell that by being on the phone with her.
19 y.o. female reported to ED after having an allergic reaction to flu shot. Patient has a known allergy to flu vaccine but received vaccine after premedicated with Benadryl and prednisone. Medical records do not list exactly when nor where the flu shot was given. Patient was unable to speak in while in ED due to her respiratory issues but answered via texting and had already given herself epi pen x2. Pt received Benadryl 25mg iv, epinephrine 0.3mg im, Pepcid 20mg iv, Solumedrol 125mg iv in the ED 14:05. RT treatment. By 17:44 pt has no s/s of distress. Respirations were even and unlabored. Patient was not admitted to hospital. She was d/c home in stable condition.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Apr-2021 at 9:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 27.45.  No concomitant medications were reported.  On 15-Apr-2021, 18 vials were moved to clinic.   The vial was initially moved to the fridge on 06-Apr-2021 and proposed beyond use date was 09-May-2021.   On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 15-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.  This case was linked to MOD-2022-566976 (Patient Link).
I received my fourth dose of Pfizer on 04/18/2022 and started to experience symptoms of COVID-19 on 09/18/2022. On, 09/19/2022 I had a breakthrough case of COVID-19. I then called my doctor and was prescribed Lagevrio because I am on metoprolol. I started to feel better about four days later. I experienced a fever, dry cough, throbbing headache, my ears were both hurting, and I had some fatigue. I still tested positive on October 1st, so I tested a week later and finally received a negative result. I also experienced a rash and hives after this dose, but I got it under control because of antihistamines.
Patient's prior vaccine status was not verified when appoint make for vaccine clinic.  Patient was scheduled for 1st/2nd dose clinic instead of booster clinic.  Patient received 3rd full dose instead of half strength booster dose.  Error was not discovered until patient did not come in for scheduled "2nd dose appointment" on 11/5/21.
no adverse event; Improperly stored vaccines administered; This spontaneous report was received from other and refers to some patients. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 28-JUL-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, three dose series, lot #W014513, expiration date: 26-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).   On 28-JUL-2023, 5 patients in total and additional patients were administered the affected hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) from the lot involved in a temperature excursion at the same location (Product storage error). No adverse events reported (No adverse event).   This is a non-valid case due to no patient's identifiers.   Follow up information has been received from an other health professional on 09-AUG-2023 and refers to a 11-year-old male patient. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # 213723, expiration date: 17-OCT-2025 via Right Deltoid) and meningococcal vaccine conj (lot # AMVA767A, expiration date: ??-JUN-2024 via Left Deltoid). The patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) via Left Deltoid.    This is one of several reports from same reporter. ; Sender's Comments:  US-009507513-2309USA000746: US-009507513-2309USA000745: US-009507513-2308USA001806: US-009507513-2309USA000744: US-009507513-2309USA000747: US-009507513-2309USA000748:
On 15DEC97 two hours after vax pt exp pain and swelling at the injection site. Pt also exp nausea, vomiting, near prostration, pruritic, erythematous.  20DEC97 pt exp a rash on her scalp, face, ears, torso, extremities, edema of the face.
Patient received her second Pfizer vaccine and within 10 minutes of the administration, the patient had a rash and was itching.  Patient stated she did not feel right.  A rapid response was called, Benadryl IM was administered and patient was transported via wheelchair to Urgent Care.
Erythema, diameter of approximately 10 cm around site of injection on the right thigh, with significant swelling of the lateral thigh.  Little to no discomfort.
Very irritable & crying for >3 hours post imm without fever -> sent to ER for eval because infant wouldn't settle with comfort & TYLENOL.
Pt's right thigh was swollen by 24 hours, post vax. DTAP given in right upper thigh. Left thigh was a little swollen, also. Prevnar given in left upper thigh. On 9/3/01, follow-up call; there are 2 lumps or knots, one in each upper thigh.
SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; 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 not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported,1 total administered on an unspecified date in 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date in 2021, the patient experienced suspected covid-19 vaccination failure and covid-19 infection. The reporter mentioned a news story she saw on 11-APR-2021, that reported a family of 4 who received covid-19 vaccine ad26.cov2.s a few weeks ago, ended up getting covid-19 infection after vaccination. The reporter did not had any other details. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection and lack of effect was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be voided based on the product quality complaint evaluation/investigation performed. This case, from the same reporter is linked to 20210422603 and 20210422632.; Sender's Comments: V0: 20210422928- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
PATIENT SAID HE HAD A ROUGH 36 HOURS AFTER THE SHOT. HE HAD FEVER, CHILLS, NAUSEA AND FATIGUE.
I became very sick with flu symptoms after receiving the vaccine, but at first I thought it was just a coincidence as I have had the flu vaccine before without issue. By 02/19, I had a fever, body aches, a terrible cough, diarrhea, a headache, and I was feeling terrible. So I left work to go to the urgent care. They had me try a phone appointment first, where I was recommended to see the doctor - so then I waited in the urgent care facility to be seen by Dr. They tested me for the flu, pregnancy, even though she said the test was inaccurate and high chance I had the flu even if it gets a negative, and they x-rayed my lungs to check for pneumonia. I was prescribed Tamiflu 75 mg twice a day and Benzonatate 100 mg three times a day. I also took over the counter ibuprofen as needed. I tried to go back to work the next Friday 02/22, even though I was still feeling very ill - all of my symptoms persisted except fever (though possibly masked by ibuprofen), diarrhea, and body aches. But I ended up leaving again early as my left ear was ringing, felt clogged (loss of hearing), and I just didn't feel right. I did a phone appointment with Dr. who prescribed me 500 mg Amoxicillin twice a day. I had high hopes this was going to be it and I would get better. But by Monday 02/26, my ear was worse and my left eye was also red with discharge. My other flu symptoms had lightened up quite a bit though, as I was not coughing like I had been. I went back to the urgent care and saw Dr. again, who confirmed my left ear was infected and then said my throat was red and it appeared I'd had post-nasal drip for a long time, so she also recommended a variety of over-the-counter allergy treatments such as a saline nose rinse three times a day, allergy medicine once a day (like Zyrtec - I bought generic version), flonase spray two sprays in each nostril twice a day, and a warm salt water rinse three times a day. I was also prescribed Polymyxin B - Tremethoprim 1 mg/ml for my eyes, 1 drop in each eye four times a day. It is now 02/28 and my eyes are more red than they were yesterday, and my hearing in my left ear is more muffled. There is also a constant ringing in my left ear since 02/22. I do not feel congestion at all besides my eye and ear. My other flu symptoms seem to have cured. I'm very concerned as all of this began directly after I received the vaccine. I know it's possible it is a coincidence and that I had been carrying the flu when I was vaccinated, but it seems like too much of a coincidence.
Ring-like appearance around the area; Large that looked like fat deposits under the armpit of the same arm under the vaccination area; Floaters on the eye; Extremely fatigue; Red, swollen, and itchy rash; Red, swollen, and itchy rash; Red, swollen, and itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Floaters on the eye), RASH PRURITIC (Red, swollen, and itchy rash), VACCINATION SITE REACTION (Ring-like appearance around the area), VACCINATION SITE MASS (Large that looked like fat deposits under the armpit of the same arm under the vaccination area) and VACCINATION SITE SWELLING (Red, swollen, and itchy rash) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE (TOPAMAX) and ATORVASTATIN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH PRURITIC (Red, swollen, and itchy rash), VACCINATION SITE SWELLING (Red, swollen, and itchy rash) and VACCINATION SITE ERYTHEMA (Red, swollen, and itchy rash). On an unknown date, the patient experienced VITREOUS FLOATERS (Floaters on the eye), VACCINATION SITE REACTION (Ring-like appearance around the area), VACCINATION SITE MASS (Large that looked like fat deposits under the armpit of the same arm under the vaccination area) and FATIGUE (Extremely fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form as required. On 22-Mar-2021, FATIGUE (Extremely fatigue) was resolving. At the time of the report, VITREOUS FLOATERS (Floaters on the eye), RASH PRURITIC (Red, swollen, and itchy rash), VACCINATION SITE REACTION (Ring-like appearance around the area), VACCINATION SITE MASS (Large that looked like fat deposits under the armpit of the same arm under the vaccination area), VACCINATION SITE SWELLING (Red, swollen, and itchy rash) and VACCINATION SITE ERYTHEMA (Red, swollen, and itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included an intra uterine device for birth control NOS. Treatment medication also included some anti-inflammatory medication like NSAIDs which were NOS.
Moderna vaccine was received at A store on 7/16/2021 and placed under refrigerated temperature. 3 vials were transferred to store another location where 20 doses were administered beyond use date.
chills-shaking, fever, nauseous-dry heaves, faint, hot head toe, warm feeling in chest
This spontaneous report was received from a registered nurse, concerning 54 patients of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the 54 patients were vaccinated with inappropriate storage doses of VARIVAX (dose, frequency and route not reported), lot # M006722 with expiration date of 08-FEB-2018, for prophylaxis. No adverse effects were reported. The prior temperature excursion of the vaccines was greater than -15 °C but less than -10 °C (>5°F but <14°F), for a time frame of 10 hours and 15 minutes. The recent temperature excursion of the vaccines was greater than -10 °C but less than 8 °C (>14 °F but <46 °F), for a time frame of 14 hours and 18 minutes. No product quality complaint was involved (PQC). Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007136:
This case was reported by a consumer and described the occurrence of petit mal seizure in a 4 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The reporter is the mother of the patient. A physician or other health care professional has not verified this report. Medical history included egg allergy. Concurrent medications included Ibuprofen for an unspecified medical condition. On an unspecified date in October 2002, the subject received the fifth dose of Infanrix in the left arm. On an unspecified date in October 2002, less than one month after vaccination with Infanrix, the subject experienced an injection site reaction characterized as swelling and and redness. The patient was seen at the doctor's office. The injection site reaction resolved on an unspecified date in October 2002. On an unspecified date on or after the fifth dose of Infanrix in October 2002 and before 5/24/05, the subject experienced staring episodes and was also noted to make clicking sounds. The consumer reported that the subject, "had a 72 hour electroencephalogram at the 4 year checkup," however, results of the EEG were not provided. The consumer stated that she, "believes that the staring episodes are a sign of petit mal seizure, though no formal diagnosis of seizure has been made." The staring spells and clicking noises were ongoing at the time of initial reporting, 5/24/05. Comment: Petit mal seizure was assessed as medically serious (OMIC).
Patient stated lightheadedness. VS taken 160/90 pulse 72 Patient stated that she does NOT take insulin or any other PO blood meds or BP medication Patient given water & a banana-no change
she has all the symptoms of covid19; felt nausea,very nauseas; Throw up; very sick; couldn't eat; was dry heaving; the first dose on the 3Aug2021 and the second dose on the 9Sept2021; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), SUSPECTED COVID-19 (she has all the symptoms of covid19) and NAUSEA (felt nausea,very nauseas) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the first dose on the 3Aug2021 and the second dose on the 9Sept2021). On 11-Sep-2021, the patient experienced ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), NAUSEA (felt nausea,very nauseas) and VOMITING (Throw up). On 27-Oct-2021, the patient experienced SUSPECTED COVID-19 (she has all the symptoms of covid19). On 09-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (the first dose on the 3Aug2021 and the second dose on the 9Sept2021) had resolved. At the time of the report, ILLNESS (very sick), DECREASED APPETITE (couldn't eat), RETCHING (was dry heaving), SUSPECTED COVID-19 (she has all the symptoms of covid19), NAUSEA (felt nausea,very nauseas) and VOMITING (Throw up) outcome was unknown.            No treatment information was provided.  Company comment- This is a case of inappropriate schedule of product administration in a 79 year old female patient, with no medical history reported who experienced non serious unexpected  event of suspected COVID-19 after second dose of mRNA-1273. The event occurred 1 month and 19 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-367605 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of product administration in a 79 year old female patient, with no medical history reported who experienced non serious unexpected  event of suspected COVID-19 after second dose of mRNA-1273. The event occurred 1 month and 19 days after second dose. The re-challenge is not applicable. The benefit-risk relationship of Spikevax is not affected by this report.
Within 45 days of vaccination began to experience blurred vision and muscle weakness. Visited optometrist for new prescription but did not resolve issue. Family physician referred to cardiologist as it was believed blocked carotid was causing symptoms. Had surgery to remove blockage but symptoms continued to worsen to point of being bed ridden and transported to emergency room. Ultimately diagnosed and treated for myasthenia gravis which I attribute to the vaccinations impact on my immune system -- particularly given reports of JNJ vaccine being linked to similar rare Guillan-Barre Syndrome.  As a result, decided to submit this adverse event report related to Moderna vaccine