chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme fatigue; Heavy and achy legs; Heavy and achy legs; Headache; No appetite; Nausea; Lethargic; Injection site pain; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration in the left arm, on 16Jan2021 17:15, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and no known allergies. The patient did not have COVID-19 prior to vaccination. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive other vaccines in four weeks. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date unknown), via an unspecified route of administration in the left arm, on 28Dec2020 16:45, for COVID-19 immunization. The patient did not test for COVID-19 post vaccination. On 17Jan2021 at 08:00, the patient experienced extreme fatigue, heavy and achy legs, headache, no appetite, nausea, lethargic and injection site pain. No treatment was provided for the events. The outcome of the events was resolved on an unspecified date.
Severe shoulder pain, transient paralysis of same shoulder of injection site. Chronic pain (mild since injection).
Child developed mild cough. Was taken to doctor. Allergies were considered and treated. Cough, still mild, continued and doctor eventually tested for pertussis by PCR which was positive. Child had no whoop, no vomiting, no apnea. Was treated with Zithromax as were 2 siblings. Child was fully immunized having received DTaP on 04/08/2008, 06/11/2008, 08/18/2008, and 05/13/2009. This is reported as a vaccine failure.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the patients were vaccinated with an improperly stored dose of ROTATEQ (Lot number L048854, expiry date 31-AUG-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken and the outcome of the events was unknown. There was no product quality complaint reported. This case is linked to case number 1609USA014777 and 1609USA013289 via same reporter link. Additional information has been requested.
The next day I felt fatigued,  I have headaches,  my upper body was sore and my skin was sensitive to clothing.  I've taken advil for the discomfort.
Allergy reaction (itchiness) on arms, chest, face and throat. And swollen throat. Precautions were taken by taking 2 benadryl of 25 mg each one  Symptoms lasted only a day
Anaphylactic reaction (throat swelling), sweaty, cold skin, elevated blood pressure (211/137 mmHg) gradual onset within 15 minutes of vaccine administration.
patient started to complain of excruciating headache pain in 1 1/2 hours after receiving the FLUMIST. Mom gave her TYLENOL and said patient was feeling better since treatment. Mom will call back if headache returns or worsens.
Having a lot of muscle pain and stiffness; stiffness is horrible; I noticed that one of the Ingredient in the Pfizer BioNTech Vaccine is potassium chloride, I also take some pills of potassium chloride I take it so, Is this going to affect or something; It's hard getting up; This is a spontaneous report from a contactable consumer (Patient).  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EP7533, Expiry Date: Unknown) via an unspecified route of administration ,administered in left arm(Left shoulder) on 30Mar2021 as dose 1, single for COVID-19 immunization: Potassium Chloride (POTASSIUM CHLORIDE, Formulation: Tablet, Lot number: unknown, Expiry: Unknown) via an unspecified route of administration on an unknown date unknown dose and frequency for an unspecified indication and unknown if ongoing. Medical history included Heart disease, Blood pressure high, Cholesterol everything ongoing from an unknown date. Concomitant medications included Metoprolol 12.5mg once a day, Amlodipine 5mg once a day, Apixaban (ELIQUIS) 5mg twice a day, Flecainide Acetate 50mg twice a day all via an unspecified route of administration from an unknown date for an unspecified indication unknown if ongoing. It was reported that "I also take the water pills, 'Hydrochlorothiazide' but I do not take it every day, I was on blood thinner (clarification unknown". It was reported that on an unspecified date patient experienced "Having a lot of muscle pain and stiffness; stiffness is horrible, it's hard getting up". Patient stated Weeks before that he was having muscle tightness, but it got better but the pain came back after taking the vaccine. Also stated he was having a lot of muscle pain and stiffness when he wakes up in the morning and they said it would go away in few days," What's few days, it's painful". "I was fine till I got the vaccine, I was doing good before I took the vaccine". Patient queried that he noticed one of the Ingredient in the Pfizer BioNTech Vaccine was potassium chloride, he also takes some pills of potassium chloride he takes it so, was this going to affect or something. Due date of second shot was on 20Apr2021.Patient did not receive any treatment for the events ("No, when I have muscle tightness, I have to do exercise. I took the Tylenol; it is 500 mg, but I only take half of it. I take it in the morning sometimes in the evening depends on the severity of the pain"). Patient did not receive any treatment for events. The Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 03-JUN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Felt like my head was spinning a few times after 7:00 p.m. on April 11th. Took Tylenol, Vitamin C, and D and took a small nap from 8:00 p.m. until 10:20 p.m. Thereafter the head was a bit heavy. But after waking up on 12th April, all the side-effects mentioned above were gone.
Pt developed chest pressure and fullness in his throat and tongue 20 minutes post 1st vaccine
LDL shot up 30 points.; Cholesterol level went up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "stent placed", start date: 18Jul2023 (unspecified if ongoing); "CAV" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 02Oct2023 as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER)), for COVID-19 immunization. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious) with onset 25Oct2023, outcome "unknown", described as "Cholesterol level went up"; LOW DENSITY LIPOPROTEIN INCREASED (non-serious) with onset 25Oct2023, outcome "unknown", described as "LDL shot up 30 points.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of low density lipoprotein increased, blood cholesterol increased. Additional information: Before she was not taking her medication as well as she should have been. However, now, she is taking it how should take it. Now she is eating better and lost a few pounds. She have been taking medication, eating better, exercising, going to cardiac rehab. Her LDL shot up 30 points. It was always in the 130s and now it's in the 160s. She was shocked that it went up to 160 from where it was. When she had blood work on her last report the LDL was 160 on 25Oct2023, that is when she found out cholesterol level went up. Prior to this, it was 136, and prior to that 133, and before that it was 124. All her cholesterol levels went up, but in particular LDL went up a lot. Triglycerides stayed the same practically. She could not understand why because she was eating better. Dropped pounds from last results and taking pills, the statins religiously. She knows she did not take it as well before. She is shocked this occurred and she believes it is due to the booster. She knows what her behaviour has been like with the last 3 test.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Pt. turned white, had trouble breathing & almost passed out. Was transported to ER by paramedics. Was discharged from hospital with no known symptoms 30 mins later.
I experienced a horrible headache with vomiting for at least 8 hours on 03/27/2021. My left arm at injection site was burning and red for 2 weeks with a lump. After the lump went down I have a permanent indent in my arm at the injection site.
2 shingrex shots in 2019. Now dr diagnosed shingles/ Suspected vaccination failure; Now I have shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both Shingrix dose in 2019 and in 2021, her physician said that she do had shingles. When that was over, should the patient get the 3rd booster Shingrix shot. The patient inquired, so how do she know if the Shingrix shot gave her any immunity and obviously there was an issue since, she now had shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Chills; injection site pain/tenderness; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ett9899), via an unspecified route of administration on 19Dec2020 09:00 on left arm at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient experienced chills, body aches, headache, fatigue, injection site pain/tenderness on 20Dec2020 at 12:00 PM. The treatment of the events included Tylenol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
covid+ Narrative: Patient with diagnosis of chronic respiratory failure with hypoxia secondary to COPD, dependent on oxygen/steroid, GERD, Rosacea secondary to long term steroid use, CAD, HLD, HTN, Diet controlled DM, Granulomatous disease of the lungs, Hx Abnormality Imaging of the lungs early 1990's- further imaging resolved without treatment, Vitamin D/B12 deficiency, Chronic rhinitis, Adjustment disorder with anxiety, Osteoarthritis of multiple joints. Patient admitted 3/19/21 with +COVID symptoms/test. Transferred to facility 3/27/21 with new onset Afib/further respiratory decompensation requiring NRB/Amiodarone gtt. Was made comfort care for Patient request and placed on MSO4 gtt. Patient passed away 3/31/21 at 1640 of Acute on Chronic respiratory failure secondary to COPD/COVID with daughter at side.
JOINT ACHE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the patient experienced joint ache. On 12-APR-2021, the patient experienced fever. On 12-APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, fever, and headache on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210832866.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional by an other manufacturer (Pfizer Inc.) was received on 02-MAY-2023 and concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included: heart attack, and concurrent conditions included: coronary artery disease, and hypertension, and drug allergy (Lisinopril), and other pre-existing medical conditions included: The patient itself other health professional (nurse) and was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAY-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 51 years old. Concomitant medications included amlodipine for drug used for unknown indication, atenolol for drug used for unknown indication, atorvastatin for drug used for unknown indication, hydrochlorothiazide for drug used for unknown indication, and losartan potassium for drug used for unknown indication. On 22-APR-2023, treatment medications included: nirmatrelvir/ritonavir. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection. This report was non-serious.
12 year old patient under dosed with the Pfizer 5-11 year old product
Hive on arm, fever, headache - 2 days after Imm. Feeling better on 11/21.
Normal effects after receiving vaccination 1 and 2 (felt nauseous a day or two after). Booster vaccination was also normal symptoms after receiving. After each vaccination, menstrual cycle came a week after each dose. After given the booster, my right arm was numb and laid in bed the following day. Recently, I've been having headaches, fatigue, trouble sleeping at a decent time in the evening and trouble waking up before 12 noon. Feeling nauseous lately (aware I'm not pregnant, just finished my menstrual cycle). Also, had a panic attack about 2 weeks ago, was in and out of the ER the same day. Went to see a physician and informed me that I'm having headaches from anxiety and mild-depression.
Bruising around injection site in days following vaccine administration. Tremor in arm in days following that.
Redness, induration in arm of injection site; fever. Diagnosed as cellulitis.
Next day -sore arm. By evening, felt flu like symptoms and cystitis set in Called in sick that Monday and Tuesday.  Went to work Wednesday-Friday  Went to ED Friday night feeling awful?..joint paint in all joints?.. short of breath, severe cystitis with gross hematuria, really unique dizziness,   Had a severe UTI >180,000 WBC with clumps  Started getting a couple Pemphigus blisters   By the following Monday, I called 911. Something was seriously wrong. I just didn?t feel right.  BP >200 sys  Heart rate 130?s sustained  Feeling of impending doom Severe dizziness  Swallowing difficulties   Went off work onto disability Had a does of Rituxin for flare up of Pemphigus Vulgaris   Coincidence?  My body says it?s directly related to vaccine.
really sick; face is swollen; Under the eye is swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), SWELLING FACE (face is swollen) and SWELLING (Under the eye is swollen) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-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 ILLNESS (really sick), SWELLING FACE (face is swollen) and SWELLING (Under the eye is swollen). At the time of the report, ILLNESS (really sick), SWELLING FACE (face is swollen) and SWELLING (Under the eye is swollen) 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.   Treatment details included antihistamine.
This 8 yo child developed varicella on 04/29/04 after having had the vaccine 10/05/96
Within 24 hours of receiving 3rd moderna vaccine I started having gross hematuria, this is the first time I had ever had it. I saw urology and ruled out bladder causes, then had a biopsy of transplant kidney 11/13/21, biopsy showed positive IGA glomerulonephritis. This causes 2 Hospitalizations and ongoing treatment. There have been case studies of IGA glomerulonephritis after Covid vaccine.
PATIENT FELT DIZZY,  FAINTED AND WAS NOT RESPONSIVE FOR FEW MINUTES. LATER HE REGAINED CONSCIOUSNESS,  FELT COLD , CONFUSED AND WAS SWEATING.  CALLED EMS AND THEY DID A ROUTINE CHECK, ALL VITALS WERE NORMAL AND PATIENT REFUSED HELP
administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml ); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose ( 1 ml ) -than-authorized dose ( 0.5 Ml )) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-293520, MOD-2021-292849, MOD-2021-292850, MOD-2021-293335 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 22Mar2023. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a other health professional refers to 4 year old patient unknown gender. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L019297, expiration date: 18-AUG-2017, via intramuscular route for prophylaxis. The vaccine underwent temperature excursion of 0.8 degree Celsius (also reported as 0.8 F) for 24 hours 30 minutes. There was previous temperature excursion. Call was because of a data logger. It was reported that the patient's age did not match the age indicated for GARDASIL 9. No adverse effects were reported. No product quality complaint involved. No other information was available.
? Acute pulmonary embolism with acute cor pulmonale  ? Pericardial effusion ? Acute hypoxemic respiratory failure  ? Hypertension PE thrombectomy
fell getting out of bed when getting up in the morning, stroke affected leg gave out with no warning. weakness increased in left arm, poor disrupted sleep, loss of appetite
09/10/2021 @ 0830AM Patient walked in clinic for possible COVID Vaccine (Moderna) reaction. Patient states he received Moderna vaccine 1 week ago (09/02/2021) in the right arm. Reports 2-4 hours later he was eating cereal and his Left  Arm became flaccid and numb. Patient states that he is feeling normal overall otherwise, and the affected  left arm is getting better since then. Clinic Lead and Pharmacist evaluated patient and asked the triage nurse for further assessment.   RN Assessment: 0900 patient sitting in waiting area, A/Ox4, Pupils round, 3mm, left not reactive to pen light, movement in cardinal directions noted, no facial droop, No slurred speech.  No SS of respiratory distress, no complaint of chest pain or anxiety, no complaint of headache. No report of lower limb edema. Right arm Full ROM, Left Arm raise to level of shoulder, wrist flexed and unable to straighten, Able to pronate and supinate forearm, Grip strength unequal<right.  No arm sway/ no loss of balance noted. Patient denies history of Stroke/CVA,  Reports Hx of Bells Palsy, unknown cause,  Reports diagnosis of High blood pressure. Reports running out of blood pressure medication (amlodipine) yesterday. Reports smoking cigars. Vitals:  0908 = 198/108 Right arm sitting, 84, 98% RA, 16-18rr 0910= 158/107 Left arm  0912= 156/98 Right arm   RN recommends patient follow up with PCP today as patient reported he intends to do. RN gave patient HTN information packet and explained risks of unmanaged HTN. Patient demonstrated understanding verbally , expressed teaching in his own words.