chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bruise at injection site; metallic taste mouth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise at injection site) and DYSGEUSIA (metallic taste mouth) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced VACCINATION SITE BRUISING (bruise at injection site) and DYSGEUSIA (metallic taste mouth). At the time of the report, VACCINATION SITE BRUISING (bruise at injection site) and DYSGEUSIA (metallic taste mouth) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-214739 (Patient Link).
Presented to UCC on 3/7/2021 with complaints of left  leg  pain/swelling, had cervical block 03/02. when  she got home she noted some groin pain,. and this morning left leg  was so swollen. she is also complaining of  mild shortness of breath. denies chest pains, was tachy at triage. She was then transferred to Emergency Department. Per their report: The patient presents with a swollen discolored left lower leg.  She does have  discoloration and I am concerned for massive DVT and cerulea dolens.  She does  have really minimal pain to the leg except to the groin, she has intact pulses,  I have low suspicion for acute ischemia/arterial clot.  She does complain of  some mild dyspnea with exertion above baseline so I do have concerns for  possible PE.  She is hemodynamically stable, appears in no distress.  She is on  oral contraceptives, mild obesity, no other significant VTE risk factors.  I am  going to empirically start her on heparin, I have also ordered a CT PE and a CT  abdomen pelvis to check for proximal propagation of the DVT along with a left  lower extremity duplex Doppler ultrasound.    Duplex ultrasound also showed extensive left lower extremity DVT up to the  common femoral, she does have bilateral PEs without evidence of significant clot  burden or heart strain, she is hemodynamically stable with normal pulse  oximetry.  The patient also has clots proximal up to her IVC.  I discussed this  with Dr.  of vascular surgery for possible thrombolysis therapy of the  left lower extremity.  She was discussed with SOUND for admission.
Heart beating fast and hard.  More frequent get up and urinate during the night.  More chest pain.
My then 13-yr old son was given the GARDASIL 9 vaccination. He sat in the examination room for 10-15 minutes after the shot. We then proceeded to walk to the office lobby to leave when my son became white as a sheet, dizzy and nearly fainted. I was just able to get him in a chair before he passed out. For 20 minutes we sat in the chair while he felt light headed and he vomited a few times. The doctor brought out a cart to monitor his pulse and blood pressure, which was elevated initially, but then returned to normal. After 30 minutes the episode was over - but it was scary.
Headache; Chills; Exhaustion; Stiff Neck; Sores on Roof of Mouth; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 22Mar2021 at 18:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin from an unknown date and prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021, the patient experienced headache, chills, exhaustion, stiff neck and sores on roof of mouth. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, chills, exhaustion, stiff neck and sores on roof of mouth was resolved with sequelae on an unknown date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 12:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
MODERATE INDURATION AND ERYTHEMA AT THE INJECTION SITE, APPROX 7CM.  ONSET WITHIN 48 HRS AFTER INJECTION
I received my second dose on 02-19-2021. I was diagnosed with shingles on 07-24-2021. The shingles occurred on my face. I am still under treatment with my PCP due to the shingles. I am also receiving treatment with my ophthalmologist for my left eye. I have not recovered from my shingles.
Arm was still Swollen; Arm was still red; Arm still warm; Pain; Chills; Sweats every night; Pain threshold went down; Nausea; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced swelling arm, erythema, skin warm, pain, chills, night sweat, pain threshold decreased and nausea. On an unknown date, the outcome of the swelling arm, erythema, skin warm and night sweat were not recovered/not resolved and the outcome of the pain and pain threshold decreased were recovering/resolving and the outcome of the chills and nausea were unknown.   It was unknown if the reporter considered the swelling arm, erythema, skin warm, pain, chills, night sweat, pain threshold decreased and nausea to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-Jul-2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient received the first dose of Shingrix and after 3 days patient experienced arm swollen, red and warm. At the first night, patient experienced horrible with the pain, chills, Nausea and sweats. The patient had sweats every night so far.  The patient's pain threshold had decreased. Additional Supportive Information: Follow-up would not possible, as no contact, details were available.
Subsequently, the pt's mother reported that 24 hours, post vax, the pt experienced hives at the injection site. It was noted that the hives were local to the leg where the Acel-immune was given. Treated with Benadryl. On an unspecified date, the pt recovered.
Starting on Monday morning December 13th woke up to pains and discomfort in chest on left side.   If rolled over would be shooting pains across chest from left to right.   Had fullness, tightness and discomfort in left chest.  Did it again Tuesday morning and Wednesday morning when it happened again went to the ER.  Have been having fullness, discomfort, tightness on and off since along with shortness of breath.  Has gotten increasingly better a little each day.  Discomfort is always in the same spot on left chest.  I will list tests in the section below that have been done.  ER doctor and my follow up physician both concluded heart wall inflammation is most likely from covid booster shot on 12/9/21.   As of today, 1/5/2022 still experiencing mild discomfort & mild tightness,  worse when initially woke and some shortness of breath.
Mom phoned office, has two red bumps- one behind ear and one on waist.  Was exposed to varicella two weeks ago. Afebrile.
I had a massive headache for several days in September 2022. Then on 9/20/2022, I developed a very sore throat; it felt like I had rocks in my throat. By the end of that day, I developed a cough. It was a congested, productive cough. I finished my workday and then took a home antigen test and got a positive result. I called my physician on 9/21/2022 and arranged a telehealth appointment with her. She prescribed molnupiravir. I was to take four capsules twice a day for five days. I began taking the medication on 9/22/2022. During this time, I was extremely tired. I lost my senses of taste and smell at some point. I drank lots of tea with honey, because I know that honey has antibacterial properties. After three or four days of the antiviral, I began to feel better. It took several weeks before I began to regain my taste and smell, and even months later, things didn't smell or taste right. It's been several months since I had COVID-19, but I experience occasional swelling of the feet, though I don't know if it's related to that. I also had insomnia prior to having COVID-19, but since having it, my insomnia has been much worse. And then there are weekends in which I want to do nothing but sleep, but I don't know if it's because my body is worn down by that point. Before I had COVID-19, I had a history of depression. I had taken Zoloft until May 2021, when I was switched over to Cymbalta. After I began Cymbalta, I developed serotonin syndrome. I subsequently had to be taken off the Cymbalta, and I haven't taken any other antidepressants since then. Since having COVID-19, my depression has become even worse than before.
slight fever; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, PYREXIA (slight fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided   This case was linked to US-MODERNATX, INC.-MOD-2021-029277 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-029277:MOD21-025933
11/13/2021 - arrives to ER from nursing home with complaints of altered mental status and hypoxia, with known diagnosis of covid pneumonia on 11/8/2021. Received monoclonal antibodies on 11/9/2021- apparently tolerable acute respiratory failure- received 2L O2 at nursing home. In ED patient found to have sepsis- 101 temp, HR 101, O2 sat 88% -placed on 100% BIPAP. Tested covid positive on admit. Chest Xray showed severe COPD with possible right base infiltrate. CRP 17.3, Started on 15L O2, continued BIPAP, high-dose steroids, doxycycline,cefaxitrone, IVF NS. H/O kidney disease  with acute kidney injury, crt 4.5, BUN 72, NA145, HCO3 19 remdesvir held, started baricitinib 2mg daily. Unable to give DVT prophylaxis  due to black tarry stool. Pt 15.5, INR 1.32 -holding heparin to r/o GI bleed 11/15 - CRT 5.3, EGFR <12- anion gap 14,metabolic acidosis, hypovolemic hyperosmolar hypernatremia with hyperchloremia - switch NS to .45% saline, oral bicarb 650mg tid. Antiembolism stockings applied for DVT prophylaxis, antibiotics and steroid continued 11/16 - Heparin started for DVT prophylaxis 11/19 - hypernatremia resolved- .45% saline d/c, Cr improving 4.5/5.7/5.3/3.8/3.4/2.8/2.4 - d/c IV hydration, continuing bicarb - anion gap 7 11/26- severe resp distress - chest xray revealed worsening of bilateral pneumonia/newly imposed hospital acquired. Cefepime IV, Flagyl, 30L HF O2 - increased O2 demand. Last covid swab 11/24 was positive. WBC 19. AKI back to baseline - Lasix initiated 11/27- d/c baricitinib. Hold Lasix - worsening renal function. Cr 2.8, BUN 45 12/4 - Covid vs HA pneomonia improving - weaned to 8L O2. Antibiotics continued. AKI stable. Heparin continued for DVT prophylaxis. 12/5/2021 - repeat covid swab negative 12/6/2021 - WBC count elevated 32.8 from 21.2, ANC 29.8 from 18.4, CRP trending down to 1.9 from 3.2. Chest xray shows left perihilar consolidative infiltrates similar, multilobar pulmonary infiltrates, and cardiomegaly, similar to prior exam. Repeat CT chest shows severe pneumonia left upper lobe with small parapneumonic effusion. O2 requirements 1-2L. Try to wean off. Heparin continued. 12/8 - WBC 36.3. Persistent leukocytosis/pneumonia -Current antibiotics held. Started on Meropenem and Linezolid. Continue Prednisone with taper, Doxy d/c. On room air, SpO2 greater than 9 12/9- H&H 7.5, 22.4 - down from 8.4, 25.4 on 12/8 - 1 unit RBC given 12/10- Bronchoscopy performed. Bronchoalveolar lavage grew E.Faecium, VRE +ve. Leukocytosis trending down to 27.6<--29.2 wbc. Meropenem and linezolid, prednisone continued.  12/13 - switched Meropenem to Ceftriaxone. Bumex initiated for signs of overload - course ronchusm/b/l upper extremity edema.  12/14 - Aspergillus Fumigatus just positive positive - Voriconazole added - 6 month regimen. 12/16 - H&H 6.9, 21.6 - 2 Units RBC given. - Hemoglobin stable at 8.6 following transfusion 12/22 1 unit transfused RBC - H&H 7.3, 21.8 12/24 - WBC normal 10.0, Hemoglobin 8.2 12/25 Hemoglobin 8.4 continued improvement. 12/27 - Completed 14 days IV Zyvox, last dose of ceftriaxone. Will continue Voriconazole. Preparing for discharge.  12/28 - Discharged
Throat feels like it is swollen inside and a little trouble swallowing. Took regular allergy med this AM.
Caller stated after injection  at bout 9pm caller had severe headache with nausea and pain at injection site . Caller stated this morning she felt a bit better.
site of inj became swollen & inflamed w/in 2hr;in morning began w/aches & pains bones aching;progressed to becoming unable to walk;it hurt to walk & hurt turning neck;arm stayed swollen for 3mo;
I experienced pins and needles all over my body. Also extreme body aches even a week later,
Product administered to patient of inappropriate age; Wrong product administered; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-Jan-2022 with the following VAERS Primary ID 1788308. The original narrative from the sender is the following:  "Administered Rotavirus vaccine IM instead of PO as specified by manufacturer. No adverse effects were reported by parent".  The causal relationship between Vaxelis and the events "Product administered to patient of inappropriate age and Wrong product administered" were assessed as not applicable due to the nature of these reported events.  Of note, these events do not concern Vaxelis, but rather Rotavirus vaccine. Vaxelis should have been considered as a concomitant. However, the case was databased to mirror what was reported in VAERS.  No further information is expected.
6 days p/vax pt devel a pruritic red rash of the inject site 5 by 6 cm;
The day after I had received the Moderna vaccine, a big red bump that admitted heat showed up right under the injection site. It is painful to move or lift the arm that was injected. Later that night, I ran a fever of 101.8 and was freezing cold. My face felt like it was burning and my head felt like it was going to explode. I did not take any over the counter treatments as I?ve read is not recommended to do. Fell asleep early then the next day (2days later) still have the bump on my arm which is bigger. I am currently using a cold washcloth to cook it off and see if it reduces the size. Still have a headache and loss of appetite.
fever; arm was sore and painful to move; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore and painful to move), CHILLS (chills) and PYREXIA (fever) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore and painful to move) and CHILLS (chills). On 09-Feb-2021, the patient experienced PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm was sore and painful to move), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: degree Celsius 37-37.9 degrees Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up information received contains updated outcome - events resolved after 2 days of vaccine. On 27-Jul-2021: No new information was provided.
Localized rash on the arm/shoulder that looks like purpura: small reddish blue dots , not itchy , not raised
Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced BELL'S PALSY (Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult) (seriousness criteria disability and medically significant). At the time of the report, BELL'S PALSY (Bells palsy, Blink reflex abnormal, Facial discomfort, Eating disorder, Swallowing difficult) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. Patient received Steroid injection.  Eye Lubricant as treatment medication. patient had to wear a patch and use eye lubricants to prevent permanent eye damage. Was told this may last for months and sometimes for life. This had affected their whole life.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Given TdaP at approximately 1430 on 6/9/08. At approximately 0300, 6/10/08, began to "feel ill" with fever (101), vomiting, "feeling of low glucose", sweating, and "syncopal by morning", while at home.  Stated that during a syncopal episode, fell in kitchen and hit left ear on kitchen counter; thin laceration, approximately 3.5 cm noted on upper third of left ear.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical, drug and allergy history or concurrent conditions. On 30-NOV-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU lot # N022035 and expiration date 11-NOV-2018 intradermally rather than the recommended subcutaneous route, for prophylaxis. No adverse reactions were reported.
Generalized tonic-clonic seizure on 4/14/2010. No additional treatment.
Trouble breathing while sleeping, dry throat, red itchy eyes, very tired, cough and runny nose
Any food that I put into my mouth tasted unpleasantly bitter.  I first noticed this at dinner a few hours after the injection.  The effect increased throughout the following day, and then tapered off the day after that. The total effect lasted about 36 - 48 hours.  Everything returned to normal.
Lethargic and crying for 12 hours.  Up all night crying after vaccines.  Screaming, not eating well and pale flat pain.  Patient recovered within 1 day.
onset of lethargy & irritability 24hr p/vax w/episodes of resp diff & suspected apnea
Has vomited 3 times so far, tiredness, sleepiness, stomach pains.
Could not stand or walk Shooting Ppin in right arm Achiness Confusion High Blood Pressure High Heart Rate - 116 Trouble speaking No appetite
Seizure, difficulty breathing and a fever at home. Squad took to local hospital unable to control seizure. Life flighted to hospital. Fever lasted 3 days. Rash on buttock lasted 4-5 days. Diagnosed with Roseola on 4/25/2014.
Myopericarditis on April 10, 2021, followed by 40 strokes on 4/25 caused by myopericarditis, then 2 more strokes on May 30
Breakthrough case admission after 3 vaccines  Pfizer 4/28/21 lot# Ew0176;  Pfizer 5/28/21 lot# Ew0186;  Pfizer 1/19/22 lot# FJ6369
Got vaccinations Thursday night. No side effects, save a sore arm the following day. Woke up Saturday morning with a terrible rash. Very prominent on my face, secondarily on my neck and inner arms, plus a few isolated spots on my forearms, torso, and legs. Rash is made up of itchy, raised, red bumps with a few spots developing into blister-like pustules filled with clear fluid.
4-6hr p/vax pt exp high fever & chills;fever persisted for 6 days & then resolved;addtl exp myalgia, mild lymphadenopathy & moderate elevation of liver function studies;ER visit required;tx ASA;found to have exp hypersensitivity rxn;
Felt fatigued the day of the shot.  Arm pain came on gradually and worsened by evening, even though I was moving my arm a lot.  Had trouble sleeping due to arm pain.  Next day slightly better.  Second day much better.  Third day pain completely gone.
severe headache, fever, chills, sweating, arm pain, swollen lymph notes, nausea, weakness, dizziness.  I have never been so sick in my entire life.
Redness on upper left arm, blood spot similar to a small bruise (1/4 inch in diameter). Pt counseled to do cold compress/MOTRIN/BENADRYL. If no improvement seek medical attention. No rash or hives or resp issue.
Three months post vax, the pt became infected with chickenpox. His mother was reported with chickenpox following exposure to varicella from her son and subsequent vaccination with varicella virus vaccine. Additional information has been requested.
no additional AE; temperature excursion for one vial of VARlVAX; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 17-SEP-2021, the patient was going to be vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U010398, expiration date 01-APR-2023 (route of administration not provided) for prophylaxis, however, the vaccine was stored at room temperature (72 degrees Fahrenheit) for 1 hour and 25 minutes. Due to this, the vaccine was not administered. No adverse event was reported.
Headache, Myalgia, Fever, injection site pain, fatigue Narrative:  Employee reports injection site pain/discomfort, fever, chills, headaches, body aches, and fatigue after receiving 2nd dose of vaccine. No medications were used for symptom relief.