chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bad redness after a week taking the 1st dose; 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 ERYTHEMA (Bad redness after a week taking the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Bad redness after a week taking the 1st dose). At the time of the report, ERYTHEMA (Bad redness after a week taking the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
One week after the injection I  had moments of severe depression and a case of outburst crying.  Headaches and nervousness. In May I was having cataract surgery and went into Afib. and bradycardia resulting in having a pacemaker implant.  The week before  I went to my primary doctor and had no problems. I have not had any problems with my heart since surgery.  Now every day I hurt and feel tired, irritable, and depressed. I feel this has something to do with the Johnson and Johnson shot. I take a flu shot every year and now I am afraid to take one because I don't know what might happen.
the vaccine has ruined her life; she can´t breath; she feels she is going to die; Her body is stiffening up; Her body is hurting; Her weight is dropping really fast/she is losing a lot of weight; She is feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up) and PAIN (Her body is hurting) in a 51-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.     Previously administered products included for Drug use for unknown indication: Pfizer Vaccine and Pfizer Vaccine. Past adverse reactions to the above products included No adverse drug reaction with Pfizer Vaccine and Pfizer Vaccine.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up), PAIN (Her body is hurting), WEIGHT DECREASED (Her weight is dropping really fast/she is losing a lot of weight) and MALAISE (She is feeling sick). At the time of the report, IMPAIRED QUALITY OF LIFE (the vaccine has ruined her life), DYSPNOEA (she can´t breath), FEELING ABNORMAL (she feels she is going to die), MUSCULOSKELETAL STIFFNESS (Her body is stiffening up), PAIN (Her body is hurting), WEIGHT DECREASED (Her weight is dropping really fast/she is losing a lot of weight) and MALAISE (She is feeling sick) outcome was unknown.            Concomitant medications and treatment information were not provided by reporter.  The patient received two doses of the Pfizer Vaccine and that patient received a third dose against patient will. It was injected illegally by a shelter worker. The patient believed the third dose that patient received was a Moderna COVID-19 Vaccine, because patient was having side effects.  The vaccine was administered two weeks ago.
This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (experiencing symptoms of sickness in stomach, no vomiting) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010a21a) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (experiencing symptoms of sickness in stomach, no vomiting). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Stomach discomfort, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (experiencing symptoms of sickness in stomach, no vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reportedly, the patient was taking 7-8 unspecified concomitant medications. The patient's additional treatment medications included unspecified acid reflux medicine. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Fax response requesting re-fax of ADR with patient's full name added to document.
No additional AE's/PQC's were reported; reporting a temperature excursion for VARIVAX/ have been administered to several patients since the escursion; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  On 10-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose or frequency 1 (units not provided) (route of administration, vaccine scheme, anatomical site of vaccination were not reported; lot number T041685 has been verified to be valid, expiration date reported and established as 10-DEC-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 11.3 Fahrenheit degrees (°F) during a time frame of 15 minutes. There was no previous temperature excursion. No adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006576:
woke up couldnt move muscles or joints, horrible chills, nausea, fatigue, vomited, headaches
pt recv vax 20FEB97 & 25FEB97 pt devel a positive PPD test;pt reported that never had a positive test before;
Had HPV #1 approximately 4pm. -6-7 hours later developed hives and stomachache ate shrimp for dinner- has eaten again without hives.
12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, runny nose , severe headache, mild palpitations, my whole body hurt. 12/24 I couldn't breathe through my nose at all , no taste or smell for 24 hours, 1 week after I wasn't getting better my lungs sounded junky , 12/31 I went to the urgent care, I got tested and was negative, I had pneumonia , I was sent home with antibiotic, steroids, inhaler.
Patient reports having developed Bell's Palsy and ringing in the ears about 5 months after receiving the vaccine
I initially experienced numbness in left arm. Hours later I had shortness of breath, dizziness, nausea, body aches, headache on the left side of my head, chills and stiffness on the left side of my body. I also experienced weakness I couldn't even lift a pen. My doctor wanted me to come in but I couldn't drive. He told me to take 2 Aleve. It didn't subside until Sunday 03/20/2022.
became symptomatic on 7/24/2021 and then admitted to Hospital on 7/31/2021. Still admitted as of 8/13/2021 to transitional care unit.
Reported feeling flushed, dizzy, and nausea, she reports vital signs are higher than usual.  Taken to Emergency Room for evaluation.
episode of palor & turning blue over entire body approx 8 hrs p/shot; lasted several minutes;
Noticed redness and swelling to vaccination site upon waking up. Site is warm to the touch and hard now about the size of a quarter.
Moderna - 2nd Dose  3/17/21 (Wednesday)  No problems  3/18/21 (Thursday) Woke up with fever, body aches, chills, some arm pain at 6:30 a.m.   Temperature was between 101.9 and 102.5.  Slept until around 2:00 p.m. and had small meal.  Still had low grade fever.  Took 2- 500 mg Tylenol.  Went back to bed.  At around 6:30 p.m., I woke with a fever, body aches, chills.  I noted my temperature to be 103.8.  I left message with Cancer Center after hours.  Nurse called me back about 30  to 40 minutes later.  By then, I noted my temperature had gone to down to about 102.5.  She spoke with on-call doctor and doctor said to go to ER if temperature gets to104.  I was told to take two more Tylenol and then call my oncologist about chemo the next day (Friday) as I had a chemo scheduled for that day.  Dr did check my white blood count from last week and there was no issues.  I took two Tylenol (one at 8:30 pm and one 10 pm) and went to bed.  On Friday, 3/19/20, I awoke with a normal but higher temperature for me (99) and alternated between normal and low grade all.    I called my oncologist, Dr. , and he  rescheduled chemo to the next week.  I was up watching movies and eating 3 meals on Friday. Temperature alternated between high normal and low grade all day.  Chills and body aches were gone.  Saturday and Sunday:  Back to my normal temperature.  (97.8-98.6)  I did not experience any headaches or nausea, but slight arm pain at the injection site. Thank you.
rash/She stated that her sister in law and also a third person had the same reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash/She stated that her sister in law and also a third person had the same reaction".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200153346 Different patient, same drug/event.
following day after vaccine developed low grade fever, low PO2, diarhea  nausea, weakness sharp headaches, loss of appetite
Couldn?t breath, Ambulance to ER,  Blood Test and Chest CT showed multiple pulmonary embolisms in both lungs,  hospital stay for 3 days, multiple IV doses of Heparin,  Echocardiogram showed enlarged right side of heart,  released with script for Eliquis
Information has been received from a physician concerning a child (age unknown) who was vaccinated with the first and second 0.5 ml doses of VARIVAX on 02-NOV-1995 and 28-SEP-2007 respectively. Approximately 1 year after receiving the second dose of VARIVAX, the patient was diagnosed with shingles on 13-JUN-2008. The patient sought unspecified medical attention. At the time of the report, the outcome of shingles was unknown. Follow-up information has been received from a physician who reported that the patient received the first and second 0.5 ml doses of VARIVAX on 02-NOV-1995 and 28-SEP-2007. It was reported that the herpes zoster began on 13-OCT-2008. There was no recent exposure to chickenpox or shingles. The maximum temperature of the patient reported as 98 Fahrenheit. The patient reported pain of a 4 on a scale of 1 to 10. No additional information was available. Additional information has been requested.
Patient was 17 years old at time of vaccination. Vaccine recommended for ages 18 years and older. No adverse reactions noted during 15 minute observation period following administration. No adverse reactions reported by the patient in the 14 days following vaccination.
Fatigue; Muscle soreness in the arms, neck, and upper back; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), intramuscular on left arm on 16Dec2020 13:30 at single dose for COVID-19 immunization. Medical history included obstructed sleep apnea, chronic sinusitis, and obesity. The patient has no known allergies. There were no concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at a hospital and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experience muscle soreness in the arms, neck, and upper back as well as fatigue on 17Dec2020 12:00 (starting about 24 hours after the vaccination). The symptoms were resolved by the next day (Dec2020), or approximately 48 hours after the vaccination. No treatment was given for the events.   Information about lot/batch has been requested.
Itching exterior of throat, itching between fingers, extreme difficulty breathing, swelling around eyes.
This spontaneous report was received from a nurse via a company representative regarding a currently 81 year old male patient. No medical history and concurrent condition were reported. On an unknown date in 2012 the patient was vaccinated with ZOSTAVAX, strength 19400 PFU, dose 0.65 ml for prevention of shingles (route, lot# and expiration date unknown). On an unknown date approximately in 2012, the patient experienced significant unspecified reaction. The patient has been seeing an unspecified rheumatologist since getting the ZOSTAVAX shot as a result of the adverse reaction. The outcome of adverse reaction was unknown. Causality assessment was provided. No product quality issue was involved. Additional information has been requested.
Vaccine lot # had been extended and vaccine had remained frozen until date of administration but was given 2 days after expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  no adverse side effects were reported by patient.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 17th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th August 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and allium sativum (Allicin). On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX in the right deltoid. The patient experienced shingles which were described as a small  patch. On 18th August 2018, patient was seen by the doctor and diagonsed with shingles. The patient was prescribed with Valtrex and Allicin.
I began experiencing a high pitched, singular buzzing in my ears the morning after I received the vaccination. It initially started as an intermittent noise that came and went throughout the day.  Unfortunately, the sound level and length of buzzing both increased as the days passed. By Saturday, March 20th, the buzzing was loud and continuous and was affecting my ability to carry out day to day activities. Now. on March 23rd, I hear the buzz whenever I'm awake. It's now accompanied by a headache that usually begins in the early afternoon. I haven't been able to find any respite or cure for the noise, and have been taking Tylenol to help the headache and using a white noise machine to help sleep. I'm very, very hesitant to receive the second dose if the ringing may further worsen.
Sense of smell off (things smelled like rotten eggs), sense of taste dulled, metallic taste for 24 hours
This spontaneous report was received from a vaccine coordinator, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The temperature of the GARDASIL 9 was between 9°C and 22°C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours") and between 0°C and 1°C for a time frame of 25 hours and 48 minutes (reported as "25.8 hours"). No previous temperature excursion occurred, and data logger was involved. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002794: US-009507513-1706USA002898.
FELT LIKE THERE WAS NO CIRCULATION IN THE ARMS; ARMS WERE WEAK; ARM NUMBNESS; CONSTANT TINGLING IN THE ARMS; PAIN TO TAIL BONE; FEELS LIKE PRESSURE TO THE AREA; NUMBNESS IN THIGHS; DIFFICULTY IN STANDING FOR LONG PERIODS OF TIME; TINGLING IN THIGHS; BOILS THAT WITH PUS ON STOMACH AND UNDER THE STOMACH; ITCHY RASH ON THE STOMACH, LEGS, AND BUTTOCK; MUSCLE ACHES; FEVER; MILD HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced muscle aches. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced mild headache. On 18-MAR-2021, the subject experienced injection site pain. Laboratory data included: Body temperature (NR: not provided) 103 F. On 21-MAR-2021, the subject experienced boils that with pus on stomach and under the stomach. On 21-MAR-2021, the subject experienced itchy rash on the stomach, legs, and buttock. On 01-APR-2021, the subject experienced numbness in thighs. On 01-APR-2021, the subject experienced difficulty in standing for long periods of time. On 01-APR-2021, the subject experienced tingling in thighs. On 06-APR-2021, the subject experienced pain to tail bone. On 06-APR-2021, the subject experienced feels like pressure to the area. On 10-APR-2021, the subject experienced arm numbness. On 10-APR-2021, the subject experienced constant tingling in the arms. On 12-APR-2021, the subject experienced felt like there was no circulation in the arms. On 12-APR-2021, the subject experienced arms were weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from boils that with pus on stomach and under the stomach, and itchy rash on the stomach, legs, and buttock on 21-MAR-2021, muscle aches, and mild headache on MAR-2021, fever on 20-MAR-2021, and injection site pain on 23-MAR-2021, had not recovered from numbness in thighs, difficulty in standing for long periods of time, tingling in thighs, pain to tail bone, arm numbness, and constant tingling in the arms, and the outcome of felt like there was no circulation in the arms, arms were weak and feels like pressure to the area was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 02Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 21Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm and on 09Feb2022 as dose 4 (booster), single (Lot number: FK9729), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "osteosrthritis" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR, stop date: 05Jul2022; TENORMIN; ENALAPRIL; ZOLOFT; TRAMADOL; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]; TYLENOL; XANAX; MUCINEX; SUDAFED 12 HOUR; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:The patient received COVID -19 treatment with Paxlovid from 05Jul2022 to 10Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
3 days of strong fever and chills. Could not leave house for normal activities.   Constricted chest and trouble breathing fully for several weeks. Intermittent pain in left chest.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple patients (nine patients). The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced suspected immunological vaccine failure (tested negative for antibodies). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817551-COVID-19 VACCINE AD26.COV2.S - Suspected immunological vaccine failure . This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Shoulder stiffness, pain, limited ROM. 11/17/15 doctors visit shoulder popping, numbness, pain, limited ROM. 12/4/16 doctors visit X-rays - normal. 12/22/16 drs visit same symptoms, referred to MRI. Partial full thickness tear versus impingement. 2-16 referral. 4/25/16 Surgery. Physical therapy current.
Patient left vaccine pod at 8:40am , felt dizziness, tachycardic, lightheaded as she walked. BP 114/90, FS=98, c/o nausea. Brought to Emergency room