chrisvoncsefalvay/vaers-outcomes huggingface dataset:
small rash on his arm; fever of 101.3; really bad chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (small rash on his arm), PYREXIA (fever of 101.3) and CHILLS (really bad chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (small rash on his arm), PYREXIA (fever of 101.3) and CHILLS (really bad chills). At the time of the report, RASH (small rash on his arm), PYREXIA (fever of 101.3) and CHILLS (really bad chills) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.3 (High) fever of 101.3.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-116421 (Patient Link).
4-25-2018: five blisters, each about 2-3 mm, appeared over my right eye. They were filled with clear fluid. As of today, they are gone and there is no scarring. 4-26-2018: four blisters, each about 3-4 mm, appeared on my left cheek. They were filled with clear fluid. The skin over the blisters was very "fragile" and all but one of the blisters ruptured when I very gently washed my face. For a couple of days after, tiny bits of skin flaked off in that area. (I am assuming that it was skin that was flaking off. It looked like tiny particles of white lint.) As of today, the blisters are gone and there is no scarring, although the skin where the blisters were looked a little red and "rough" for a few days. I did not feel ill and there are no lasting problems. I did have Chickenpox as a child.
Information has been received from a 40 year old female, for GARDASIL, a Pregnancy Registry product, concerning herself. The patient had no pertinent medical history and no drug allergies. The patient became pregnant on an unknown date. The LMP and EDD was not known. On 19-AUG-2013 the patient was vaccinated with her first dose of GARDASIL injection, dose and frequency unspecified. No concomitant medication reported. The patient did not know she was pregnant when she was receiving the GARDASIL. On 23-AUG-2013, the patient experienced miscarriage. The patient saw the doctor for medical attention. No treatment was given for the event. No lab diagnostics studies performed. Upon internal review, miscarriage was considered to be medically significant event. Additional information has been requested.
Soreness in my arm. red and swollen area around injection site about the size of a quarter or a little bigger. Has been sore for 2 days red area seems to get a little bigger everyday.
Patient was here to get 3rd dose of the Pediatric Pfizer Covid 19 for under age 5 y.o. Patient received the Pediatric Pfizer Covid 19 Bivalent vaccine for children ages 5 y.o. - 11 y.o. I spoke to mom at 4:30pm today, and she reports that he is tolerating the dose fine so far.
L axillary, clavicular Lymphadenopathy lasting into 10th day; more intense fatigue; worse/stronger arthralgia; nose running; This is a spontaneous report from a contactable Nurse (patient). A 53-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration, administrated in Left deltoid on 18Feb2021 (age at the time of vaccination 53-years-old), as a single dose for COVID-19 immunization at Hospital. The patient's medical history included Ewings sarcoma as a teen. The patient's concomitant medications included Omeprazole 20mg, and Amlodipine 2.5mg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration, administrated in Left arm on 26Jan2021 12:30 (age at the time of vaccination 53-years-old), as a single dose for COVID-19 immunization and experienced runny nose, Light Arthralgia, upper back/shoulders, progressing to arms, wrists, hands, Fatigue, and in bed by 7pm and sleeping 10h. No other vaccine in four weeks. covid prior vaccination was unknown. No covid tested post vaccination. Patient had no known allergies. On an unspecified date Feb2021, the patient experienced L axillary, clavicular Lymphadenopathy lasting into 10th day, more intense fatigue, worse/stronger arthralgia, and nose running. Patient received treatment as a result of adverse events which included Ibuprofen but no relief. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Severe outbreak of Herpes Simplex 1 (cold sores) on lips.  Have not had cold sores in 15-20 years.  Began day 10 after injection and is continuing. Not responsive to OTC Docosonal 10% to current time.
Patient was given H1N1 in upper right deltoid within seconds patient developed bruise then knot at inj. site. Patient was evaluated by doctor and observed for 20 minutes which doctor then prescribed Kenalog 40mg IM for itching and twitching eye. Patient felt nauseated and lightheaded. Paramedics phoned for ER treatment.
she tested positive for Covid-19; she tested positive for Covid-19; This is a spontaneous report from a contactable consumer(patient husband). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on unspecified date. The patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. Then a few days later, patient tested positive for Covid-19. Patient wanted to know when should receive the 2nd dose. Patient received the monoclonal antibody infusion as a treatment. The outcome of the events resolved.  Description of complaint: Incoming attempted transfer from regulatory authority: INT-00412862. His wife received the first dose of the Pfizer Covid BioNtech Vaccine. His wife, a few days later she tested positive for covid 19. She has now already recovered from the virus. He wants to know when she can get the second dose. Caller is being transferred to share his wife's side effects. His wife also had a monoclonal antibody infusion as a treatment. Caller disconnected prior to completion of transfer. No Additional information provided.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I experienced extreme muscle and body discomfort  after both injections.  It began about 10 hrs after the injection and lasted about 12 hours.  I have also been losing my hair since April. I do not know if it has anything to do with the vaccinations.  It has not stopped yet.
Patient began having nausea, reflux, hand tingling and chest pain on 4/18. CT head 4/18: showed trace SAH with high left frontal parietal sulci. CTA head/neck: 1.5 mm aneurysm of proximal L cavernous ICA with small pseudoaneurysm of the posterior proximal ICA.  NIR - no source of bleed found
rash (chest & back), fever, malaise, diarrhea saw PMD on 14AUG97 & dx w/rxn to MMR;
expired IPOL administered to patient; Initial information regarding an unsolicited valid non-serious case was received from an other health professional. This case involved a 4 year old female patient who received a dose of IPV (VERO) [IPOL] (lot number: P1F541 and Expiry date: 07-Dec-2020) via an unknown route in left arm for prophylactic vaccination (Expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Arm soreness, fever of 100.2, muscle aches in the legs all starting at 2am on 06/11/21. Administered Tylenol and it didn?t help
A metallic taste in my mouth that began approx 5 minutes after the injection and was gone within 15 minutes. I had the same or similar reaction with my first Pfizer covid vaccine (also reported) but not on the second shot. This was my third shot, a booster 6 months later, and I experienced the metallic taste again.
I had the most insane chills for 7 hours. It was 90 degrees outside and I had to turn The heat on. I had theee blankets on me and a sweatshirt, socks, pants. I was shaking uncontrollably for 7 hours. Then around 1am my body was on fire. It felt like my hands were burning just from touching my stomach. My sheets were drenched in sweat. I turned the air conditioning on full blast and could not cool down until 1pm the next day. During the night I was so weak I couldn?t even walk to my kitchen to get water. I had to crawl. I was hysterically crying. I haven?t been sick in a decade or two. I have no medicine at my house, I?m never sick.  This was one of the worst nights of my life.
MMR II Lot T001213 Expiration date 1/12/2022 was administered on 1/18/2022. There were no adverse effects to patient. I contacted Merck & Company to discuss with representative if a re-vaccination was necessary. Merck stated that as long as there were no temperature excursions and with the vaccine storage, they stand behind their product with in-house data to still be potent beyond the 6 days usage (after expiration date).
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age who on 31-DEC-2012, was vaccinated with a dose of ROTATEQ, oral (lot number 0777AA) (dose not reported) that was expired. The vaccine expired on 14-NOV-2012. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Mother of baby in office 06/27/02 at 3:25pm c/o lump in baby's right thigh since receiving immunizations on 06/21/02. Nurse states she used 1 3cc 25GA syringe with needle; 7mm lump palpates right anterolateral thigh. No redness, no bruises, no sign of pain to baby when palpated; hot to touch, baby very playful.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject didn't use a heavy duty Band-Aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 80 or 81 years. The patient received in SHINGRIX the arm and was asking if she could apply an ice pack to her arm where she received her SHINGRIX vaccination. The patient's arm was sore, otherwise she felt fine. No further information was reported regarding the event. The healthcare professional reported adverse event via click to chat forum.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: CELLULITIS-Medium, Additional Details: PATIENT DIAGNOSED WITH CELLULITIS. RECEIVED RX FOR CEPHALEXIN
First dose > 36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose > 36 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose > 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose > 36 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: TCR received-NNI
Rash and redness localized to injection site. Patient was seen on 6/10/19 @ 5:37 PM by CNP, mother refused treatment stating "will give her son benadryl and take son to primary care doctor if worse." Attempts have been made to contact mother for follow up on patient, awaiting call back.
About a week or two after vaccine I started feeling pain in my joints in my hands. I thought it would just away so I continued to work and do whatever. A couple of weeks later, I started noticing my fingers and feet starting to swell but it could be part of pregnancy. It does feel like carpal tunnel but my Doctor said it could be part of pregnancy or the vaccine. She recommended I wear a wrist brace. I've been elevating my hand so the swelling could go down but I still feel pain when I bend it and sometimes I get numbness and tingling in the fingers and the whole hand and arm. This is still ongoing. I've had carpal tunnel before but never had pain in my joints, so I do know this is a little different. Third Pregnancy.  38 Weeks Pregnant.
Patient became lightheaded and dizzy approximately 2 minutes following immunization. She was given a cold drink of water and cold compress to help. The patient had been instructed to sit down following immunization and did so. About half an hour later following administration of the vaccine the patient felt well and went home. No additional symptoms such as swelling of the mouth, lips, or throat were abnormal and the patient had normal vital signs.
This spontaneous case was initially received on 09-Oct-2015. The case report was received from a Health Professional and concerns a 38 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 10-Nov-2014, Batch no: 10749221A, Route of administration: Intramuscular, Dose: no information provided. No additional drugs suspected. On Nov-2014, after starting treatment with AFLURIA the patient experienced Nausea three times, Vomiting three times. Action taken: Discontinued. No treatment in office for reaction.
Information has been received from a physician concerning an 11 year old female who on approximately 01-SEP-2007 was vaccinated with the first dose of GARDASIL. On approximately 01-SEP-2007 the patient fainted a few minutes after being vaccinated. Subsequently, the patient recovered from fainting the same day as the vaccination. The physician considered the patient's experience to be non-serious. Additional information has been requested.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 5 year old patient (gender unknown). On 04-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) (dose and route not reported) instead of a dose of VARIVAX (Merck). The CMA did not specify if this dose was the first for second dose in the patient's vaccination series. No adverse symptoms reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (without issues). On 8th August 2018 13:30, the patient received the 2nd dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, diarrhea, headache, fever and chills. On an unknown date, the outcome of the general body pain, diarrhea, headache, fever and chills were recovered/resolved. It was unknown if the reporter considered the general body pain, diarrhea, headache, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient had no issues with the first dose of SHINGRIX and so was a little surprised when she had issues with the second dose. The patient was administered SHINGRIX in the right deltoid. The patient noted the body aches were all over. All started within 12 hours of the vaccination and had resolved. The patient had not reported the events to her physician. The patient's health care professional was not asked, since events were not reported to him.
Patient experienced syncope after vaccine administration and regained consciousness immediately. He was seated and did not fall, only slumped forward in his chair. After regaining consciousness, he felt nauseated and vomited several times over about 10 minutes. He was provided water and remained seated for about 15 minutes until he felt well enough to ambulate.
Patient is a COVID-19 vaccine breakthrough case who is deceased.  Patient was admitted to the hospital on 4/5/2021. He was then admitted to the ICU and placed on a ventilator before passing.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of dysgeusia (metallic taste after shots) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's medical history not reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dysgeusia (metallic  taste after shots). At the time of the report, dysgeusia (metallic taste after shots) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Patient reported back to pharmacy 3 days after vaccination with entire upper left arm red and inflamed. Patient complained of pain throughout arm as well as redness and warm to the touch. Patient stated it began 1 day after vaccination and has progressively worsened and spread. Patient saw PCP on day 3 and received a Medrol injection. Patient denied having an adverse reaction to a vaccine in the past.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored VARIVAX (Merck), lot # L006383, expiration date: 25-FEB-2017 (dose and route unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
She was being treated for kidney failure, at one point her body was not responding to the treatments and they put her in Hospice. She was in hospice for some 5 days. She had been dying for days and in one of the rounds around 6 am on 2/2/2021, the caregivers accompanied her until she no longer had vital signs.
muscle pain in back, shoulders & knees constant;pain while walking;saw MD 4/20/99;MD believed d/t shot;tx w/pred & pain med;nausea 4/21/99 p/taking a shower in AM;pain started next morning p/shot given @ school;
Received Typhoid VI and tetanus/Dip to left deltoid on 9/29/09 - says experienced slight swelling/pain left arm same day - says went to personal physician on 10/9/09 with complaints of pain in arm pit (left side)- says pain on arm pit started around 10/4/09 - Says pain and discomfort easing up today as compared to when episode started.
Case number PHEH2013US009123 is an initial spontaneous report received from a medical assistant on 19 APR 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M120127 and expiry date: DEC 2014) at dose of 0.5 ml intramuscularly on 02 APR 2013. On the same day after vaccination, he experienced redness and swelling at the injection site on left arm. These symptoms were subsided the next day. The outcome of the events was reported as completely recovered. The seriousness and causality of the events was not reported.
severe thrombocytopenia, mucosa bleeding causing hemoptysis, cutaneous ecchymosis treated with IVIg, pulse steroids, and platelet transfusion.