chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; SHIVERING; TEMPERATURE IT WAS 105.3; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose was not reported, 1 total, administered on 03-MAR-2021 19:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 105.3. On 12-MAR-2021 03:00, the subject experienced shivering. On 12-MAR-2021 03:00, the subject experienced temperature it was 105.3. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of shivering and temperature it was 105.3 was not reported. This report was non-serious.
Chills, muscle aches (~6 hours)/fatigue, headache (~24 hours); Advil; symptoms resolved after 24 hours
I just noticed I have a lump on my arm at the injection site. It feels itchy at time and is slightly tender.
Injection site pain, tiredness, headache, muscle pain, joint pain, swollen lymph nodes, and over all not feeling well.
Development of fever blisters (cold sores).   I've had cold sore/fever blister before.  For the past 30 years I would typically get ONE cold sore roughly about every 3-4 years.  Typically it was an indicator I was about to experience an illness.  They were VERY rare and always noted as I will not kiss my children or wife when I would get one.  It would always appear in the exact same location on the upper left part of my top lip.  Very minor cold sore but a cold sore none the less.  My reaction to the 2nd shot was pretty strong.  I had a 102F fever starting at 10PM the evening after the second vaccination.  Very strong muscle contractions and joint inflammation.  The fever and soreness disappeared about 36 hours later and I was fine.  Fast forward a week or two (from the second shot) and I developed an unusual coldsore on my lower lip.  It appeared almost immediately.  I began to apply Abrevia (10% Docosanol) right away.    Honestly it was a very unusual cold sore.  Much larger than any cold sore I had ever had.  It even caused bumps on the  interior part of my lower lip.  This has never happened.    In the past this cold sore would be it.  Then I would be free of them for an extended period.  As of April 21, 2021, I've had 2 additional cold sores.   This is three cold sores in a period of less then 5 weeks.  My diet, exercise and lifestyle have not really changed.  This is VERY odd.
Besides the nausea, cold sweat, and dizziness. Pt stated, "It was more like I could not get air in my lungs." Took couple of days to get over nausea and dizziness.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 05 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
After 8 days of vaccination started developing hives all over the body, lips and around eyes. Have been on anti histaminics since then and still experiencing flare ups everyday. Hives are extremely itchy and are spontaneous.
Received the first dose of Moderna and six days later, I started to notice increase pain, redness and swelling at the injection site.  Called my PCP office & got an appointment the same day.  Per PCP, I developed cellulitis and was given a round of Keflex.  This has resolved the issue.
got dizzy; Soreness at the injection site; Arm felt a little hard; Blood pressure shot up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Blood pressure shot up), LIMB DISCOMFORT (Arm felt a little hard), DIZZINESS (got dizzy) and VACCINATION SITE PAIN (Soreness at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, COPD, Glaucoma, Post-traumatic stress disorder and Herniated disc. Concomitant products included TELMISARTAN (MICARDIS), CELECOXIB (CELEBREX), GABAPENTIN, LAMOTRIGINE (LAMICTAL), ATORVASTATIN, LANSOPRAZOLE (PREVACID), HYDROCHLOROTHIAZIDE, MONTELUKAST, BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), ALPRAZOLAM, MULTIVITAMIN [VITAMINS NOS], VITAMIN B12 NOS, VITAMIN D NOS, UBIDECARENONE (COQ10 [UBIDECARENONE]) and BIOTIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HYPERTENSION (Blood pressure shot up). On 27-Feb-2021, the patient experienced LIMB DISCOMFORT (Arm felt a little hard) and VACCINATION SITE PAIN (Soreness at the injection site). On an unknown date, the patient experienced DIZZINESS (got dizzy). On 01-Mar-2021, LIMB DISCOMFORT (Arm felt a little hard) had resolved. On 02-Mar-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, HYPERTENSION (Blood pressure shot up) and DIZZINESS (got dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included ice pack to the injection on and off for 48 hours.   This case was linked to MOD-2021-071480, US-MODERNATX, INC.-MOD-2021-071480 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up appended. Contact information updated; Sender's Comments:  MOD-2021-071480:2nd dose US-MODERNATX, INC.-MOD-2021-071480:First dose case
Information has been received from a Medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of GARDASIL (Batch and Lot No. K010215, exp. 05-MAY-2017) (dose, site and route not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001941, 1601USA001942, 1601USA001943 and 1601USA001944 from the same reporter. Additional information has been requested.
Apraxia of the Eye Lids; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration on 14May2021 (at the age of 17-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (lot number ER8737) on 03Apr2021 for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history and no known allergies.  There were no concomitant medications. The patient experienced apraxia of the eye lids on 03Jun2021. The patient did not receive treatment for event. The patient underwent lab tests and procedures which included Nasal Swab: negative on an unspecified date. The outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.
Severe tinnitus in left ear 7:35pm on Thursday, April 8, 27.5 hours after vaccination. Symptoms slowly eased but tinnitus remains 17 hours later
MODERNA COVID VACCINE BOOSTER GIVEN 11/12/21, LOT # 077C21B; pt brought to ED on 4/19/22 with dyspnea and cough x 2 days; O2 saturation 80% on RA; admitted; O2 supplementation; positive for COVID; fever; bone marrow and lymph bx done; worsening condition; prognosis guarded; DNR; rectal bleeding the morning of her death; all aggressive treatments were stopped; pt passed away in the hospital
VERTIGO, DIZZINESS, BLURRY VISION, LIGHTHEADED, FELL DUE TO IMBALANCE. PT WAS WELL RESPOND AFTER HE FELL. PT HIT IS HEAD REAL HARD ON THE FLORE DUE TO IMBALANCE BUT NEVER LOST THE CONCIOUSNESS.
NEAR SYNCOPE  BP 120/81mmHg HR 64 bpm O2 SAT 99%
L arm with flesh colored maculopapular rash = 2 in diameter around site of injection. occurred = 2 days after injection. + pruritis. Tx with moisturizing and 1% hydrocortisone cream.
Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # 664653/1337Y). Subsequently the patient experienced high fever. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a pharmacist who reported that the 34 year old male patient with quadriplegia and allergic to ZITHROMAX on 16-OCT-2010 was vaccinated into the left deltoid with a dose of PNEUMOVAX 23. The patient had received a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unknown) on 12-OCT-2010. The pharmacist also reported that on 17-OCT-2010, the temperature of patient was 103.8 degrees, he had redness and swelling at the injection site (left deltoid); the patient was hospitalized (details not known by pharmacist). On an unspecified date the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664653/1337Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from a health care professional which reported that the 34 year old male patient with gastrooesophageal reflux disease (GERD), spasms, quadriplegia and urinary tract infection at the time of vaccination, who on 16-OCT-2010, was vaccinated in the left deltoid with the first dose of PNEUMOVAX 23 (Lot# 664653/1337Y). On 17-OCT-2010 at 13:00, the patient had elevated temperature, redness and swollen to the left deltoid. The patient was sent out to the emergency room. At the time of the report, the patient recovered (date unspecified). This is one of several reports received from the same source. No further information is available.
Patient was given an annual flu shot on 9/28/2011 and reported back to the pharmacy on 9/30/2011 that she had experienced fatigue as well as GI issues after receiving the dose. Patient states that she is feeling slightly better now. Suspects it is related to the INFLUENZA vaccine.
Cough, mild SOB, uvula edema Treated with 50mg IM Benadryl and 0.3mg EPIPEN Transported to ED vis EMS in stable condition
Pt received MMRV on 4/30/14 on 5/7/14 developed large mildly erythematous papules scattered on face, neck and arms.
Right thigh subcutaneous erythema.  After erythema resolved, a subcutaneous nodule remains.
a few hr p/vax in lt thigh & mom reported blue & cold from knee to foot;this resolved p/wrapped the leg w/a warm wash cloth;also reported a fever but no temp level was reported;pt was back to nl by 30JUL;
Started with chills and body aches about 24 hrs after shot.  Headache about 36 hrs after shot. Arm was very sore and hurt to move it. Took Tylenol and that helped with the chills. No fever.
Patient woke up yesterday morning with itchy rash/hives all over body and his right foot is swollen. Patient did not have reaction with first 2 shots.
Case number PHEH2014US007736 is an initial spontaneous report received from a medical assistant on 16 Apr 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M11042) intramuscularly on 30 Mar 2014. On31 Mar 2014, next day after vaccination, the vaccination site was red. Warm compressions were applied on the vaccination site and it became bigger by the third day. The outcome of the event was condition deteriorated by the third day. The seriousness and causality of the event were not reported.
Fever, chills, whole body skin hypersensitivity, joint pain, sore throat, abdominal pain, headache.  I couldn?t believe how bad I felt.  I slept for 12 hours and awakened feeling better with no symptoms.
Pt complained of dizziness and facial numbness. EMS responded, BP 145/83, HR 78, O2 97%. Pt refused transport. Symptoms unimproved with snacks/water, pt referred to PCP/urgent care if symptoms do not resolve.
04/12/2021 11:15am received 2nd shot, started feeling goofy, terribly sick, Collapsed in the floor passed out for 14hrs found by management, admitted to the hospital. 04/16/2021 went into Cardiac Arrest. Hospitalized 11 days/discharged 04/27/2021
pain of 3 - 4 on the 1 - 10 scale in the right deltoid muscle where the shot was given.
Initial unsolicited report received from a consumer on 24 October 2016. This case involves a patient (age and gender was not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) (lot number, expiration date of product, route of administration, site of administration, dose and dose in series were not reported) on 23 September 2016. The medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had an adverse reaction- had stiffness and spasms. Patient's lab data was not reported. It was reported that patient's doctor told that the patient needed physical therapy as treatment which the patient could not afford. The outcome of the events was not reported. List of the documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 12 year old female patient. On an unknown date, the patient was vaccinated with the third dose of GARDASIL (route, lot #, expiration date were not provided). On approximately February 2014, the patient experienced hypersensitivity to sound. No treatment was given to the patient. It was unknown if the patient sought medical attention. The pharmacist stated they believed the issue started right after the third dose but it did not become apparent until about two months ago. The outcome of hypersensitivity to sound was reported as not recovered/not resolved. Additional information is not expected.
After receiving both doses of Moderna COVID vaccine in January 2021 and February 2021, my mother started becoming ill. Previous to this she was active, could drive, go to the store, the hair salon and family functions. She started not feeling well in March 2021 and May 2021. In July 2021 she was admitted to the hospital for 3 days having trouble breathing. August 2021 she was admitted again for 5 days with the same breathing issues. She was released and taken to the Emergency room again within 36 hours. She was admitted to hospital for 3 days and released to a nursing home August 25,2021. Her prognosis is not good and she will probably die soon. These COVID shots have seriously injured my mother. UPDATE: Your gene therapy KILLED my mom. She died of myocardial infarction caused by this shot you call a vaccine. STOP THE LIES, STOP THE DEATH, STOP THE VAX!!  Serious Adverse Events Serious adverse events were defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, or resulted in persistent disability or incapacity. The proportions of participants who reported at least one serious adverse event were 1% in the vaccine group and 1% in the placebo group. The most common serious adverse events occurring at higher rates in the vaccine group than the placebo group were myocardial infarction (5 cases in vaccine group vs. 3 cases in placebo group), cholecystitis (3 vs. 0), and nephrolithiasis (3 vs. 0). Three serious adverse events were considered by the U.S. Food and Drug Administration (FDA) as possibly related to vaccine: the one report of intractable nausea/vomiting and two reports of facial swelling in persons who had a previous history of cosmetic filler injections. The possibility that the vaccine contributed to the serious adverse event reports of rheumatoid arthritis (n=1), peripheral edema/dyspnea with exertion (n=1), and autonomic dysfunction (n=1) cannot be excluded. Data source: FDA briefing document external
Frequent urination beginning the morning of 2/4/2021. I took a home blood glucose test on 4/23/2021 and had a reading of 590 mg/dL. I went to urgent care on 4/24/2021. At that time I was treated for hyperglycemia. I had a blood glucose reading of 217 mg/dL. I was diagnosed with type 2 diabetes by my PCP on 4/26/2021. I followed-up with endocrinology on 10/29/2021 and was diagnosed with GAD65 diabetes, likely type 1.
Onset of symptoms at 2 hrs after received MMR and ENGERIX B vaccines. Light headed, "swimming headed", stomach upset, dizziness and pale skin with flushing to face.
PT PASSED OUT WITHIN SECONDS OF STANDING UP AFTER RECEIVING VACCINATION. SHE HIT HEAD ON A CARDBOARD BOX. ALMOST IMMEDIATELY AFTER VASOVAGAL SYNCOPAL EVENT, PT AWOKEN AND WAS FRIGHTENED. MONITORED PT FOR 20 MIN AFTER EVENT AND SHE WAS FINE.
Complained of Red rash, sore at injection site. Started 1 day after injection. Feels weak.
Immunocompromised patient received 0.25 ml for third dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Immunocompromised patient received 0.25 ml for third dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Immunocompromised patient received 0.25 ml for third dose). On 10-Sep-2021, INCORRECT DOSE ADMINISTERED (Immunocompromised patient received 0.25 ml for third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Treatment medications were not reported.  The patient was due for his fourth dose on 07-Feb-2022 and the nurse enquired whether the patient can be given the booster dose 3 days earlier.
Diffuse urticarial reaction over the bilateral upper extremities, not including the palms. No involvement of trunk. Bilateral lower extremity involvement with urticaria & pustule formation in the thighs. Confluent vasculitis appearance over the calves.
pt recvd vax;pt seemed to be acting "funny";to mom,eyes seemed out of focus & his cry was fretfull;T 102.6;was drifting in & out of sleep,seemed fussy;to PMD,felt rxn to pertussis & should not recv pertussis again;
The second and third days after the March 29 dose, I experienced sinus headaches.  I kept the worst of the pain at bay by taking acetaminophen and ibuprofen. On April 5, I began to feel dizzy, nauseated, very tired and had a severe sinus headache.  I also experienced a strong smell of cigarette smoke when no one else could smell it and there were no nearby smokers.  The nausea was pretty severe. I felt like vomiting but never did. I did have some diarrhea.  This continued at its most severe through April 6. On that date, I called my doctor who recommended I use flonase. I had also started taking Tylenol Severe Sinus.  My symptoms improved after starting the meds. My doctor also recommended I get a Covid test. I got the rapid test on April 7. It was negative.  By April 9, my symptoms were mostly gone, including the smell of smoke. I also had side effects after the first vaccination on March 8. On March 9 and 10, I had a severe sinus headache.  On March 10 and 11, I was very nauseated and vomited twice. I also experienced fatigue for about 5 days.
I had a bad flare up on my left knee,, I?ve never had one on my knee before.  I am taking daily dose of hydroxychloroquine for my rheumatoid arthritis.  This is day 3, and it?s getting better.  I am taking prednisone and Voltare.
Patient had a fall at home; was noted to be in new onset a fib with evidence of a UTI and was then admitted.    Her home BP meds were continued initially with amlodipine, losartan and dilitazem.  She was also given a dose of metoprolol due to the Afib.  She then became hypotensive and bradycardic.  Her BP meds were all stopped and she was supported with fluids and her BP and pulse normalized.  Her creatinine was improving prior to discharge. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This pt developed injection site reaction characterized by redness, warmth, induration, pain and malaise within 12 hours post vax. She was prescribed hot packs to the affected area, Motrin and Keflex for 2 days, then Biaxin. At the date of this report, the pt "has not gotten better."
Initial unsolicited report received from physician via Pfizer on 23-May-2018. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had allergy (unspecified). Lab data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Pneumococcal vaccine given on 9/13/11 to (L) upper arm. On 9/18/11 redness to (L) upper arm noted, with some edema area blanchable. No c/o of pain or discomfort voiced by resident.
Within 5 minutes I developed a strange feeling in my head, not full blown dizziness but more of a light headedness with a fullness to both eyes and a pressure sensation behind both of my eyes.  After the 1st dose I was fine for the 30 minutes of observation and about 5 minutes after leaving I had a similar reaction but not nearly as intense, It lasted for about 1 hour, the reaction to the second dose lasted 3 1/2 days progressively getting a little better each day.
rt arm hives around inj site on rt deltoid & down to forearm;ice packs applied;
Patient was sleeping and woke up around 8:30 pm and vomited. Her fever immediately increased to 101.7 (temporal).  Vomited again around 10:30 PM.  Was in the shower with mom immediately after to clean up emesis.  In the shower, she continued to having chill-like shivering, but then her entire body started shaking violently, her body went stiff, and she was not responsive.  At this time, she was still in the shower with mom.  After she stopped convulsing, she slept.  Emesis occurred again at 2:30 am at the hospital (temp 102.7 rectal).  Later that morning, she returned to her previous self, playful and happy with no subsequent emesis.