chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Periodic but persistent severe arm pain in left arm in area of flu shot.  Periodic muscle aching, moderate weakness and reduced range of motion in my upper arm - often the pain will wake me from sleep if I'm resting on my left arm.  I wait for it to subside, and it does.  Because I have had this problem when receiving the flu shot for the past three or four years I have requested the shot be given in my hip but was told that location is not available to me - only the arm.
reactions, it wasn't good; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (reactions, it wasn't good) in a 60-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On an unknown date, the patient experienced ADVERSE EVENT (reactions, it wasn't good).   At the time of the report, ADVERSE EVENT (reactions, it wasn't good) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
I am currently pregnant, very early. I had a positive pregnancy  test after my second dose vaccine. I have no symptoms yet related to this vaccine just the headaches and chills but nothing major.  I went to the hospital where they performed a Beta HCG due to me struggling with infertility issues. This pregnancy was unexpected and later this week an ultrasound of the baby will  be performed.   for my first dose, performed 01-28-2021 I experienced usual arm  soreness at the injection site and headaches.
Fever to 104 x 2 days; erythemia & swelling of inject site & upper 1/3 of arm;
Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022).    Concomitant medication was not provided.  It was reported that the vial size was 0.4 ml per vial. The vial was initially stored in refrigerator on 23-Dec-2022. The vial did not undergo any temperature excursion. Treatment information was not provided.  This case contains information for the 36th patient out of 42 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Pt lost her sense of taste and smell. She had a cough for the last several weeks, no diarrhea or GI complaints. Pt was transferred after being found to be COVID positive.
Itchy, widespread hives within 10 minutes of vaccination. Administered diphenhydramine 50 mg/ml Injected 0.25 ml IM x 1. Observation by RN and with NP.
pt recvd vax & collasped, turned blue around lips & body was stiff & shivering; thought was choking & tried to look in mouth but couldn't open it; pt confused, limp & crying; poss epilepsy;
Cardiac event; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Cardiac event".  Additional information: The reporter stated that the patient was her husband's friend who was a gastroenterologist, who also had a cardiac event after receiving the COVID vaccine. She does not know if he reported it. Neither one of them had heart issues. The patient said that should not have happened to him. They are approximately the same age and went to medical school.
Patient was inadvertently given MMRV instead of MMR; they were next to each other in the fridge and grabbed the wrong one, even though the bottle was checked.
This spontaneous report as received from a registered nurse refers to patient of unknown demography. On 24-AUG-2016, the patient was vaccinated with first dose of RECOMBIVAX HB. On 13-SEP-2016, the patient was vaccinated with second dose of RECOMBIVAX HB (Inappropriate schedule of drug administration). No adverse effect reported. No product quality complaint (PQC) involved. Additional information has been requested.
Swelling, raised, red area about 2 inches in diameter. Also a blister present 6cms below injection site.
shoulder begin to ache, by evening site was swollen to size of grapefruit and hard and hot to the touch.  At 6:00p.m, got very congested and started coughing alot,hard to breathe,(the hard to breathe part subsided after a few seconds) felt weak, tired, and could feel pain all the way to my fingertips.  felt mild nausea and headache that lasted for three and a half days.  Took nyquil two nights in a row and by Friday morning felt better but only worked half day. Did not feel completely back to normal until Sunday afternoon except for the soreness still around the site of the shot.
I immediately felt significant tingling, numbness and freezin/burning sensation through my veins, arms, fingers, legs, toes, face, nose and behind eyes.  About 3 hours after the shot I had a significant headache (migraine type), chills, nausea, and fatigue which lasted 24 hours.    The numbness, tingling/burning sensation in my arms, legs, toes, fingers, face, nose, cheeks continues 2 weeks later and keeps me awake at night.  Nothing helps it, it is constant.
I had the shot in the morning, and by the early evening, I was exhausted like I have not experienced without being sick. I did not have a choice to nap or not. I fell asleep 3! times between 5 and 11, two of the times were on the hard floor. I continued to be extremely fatigued for the next day and some of the 13th as well. I have never been so tired without being sick (or having a sick child). By the third day I felt myself again. Our daughter, 14, had the shot and had a very similar reaction and timeline. I submitted one of these forms for her as well.
pt reported high fever, congestion, h/a, SOB beginning on 7/10/99, positive ANA titer & elevated NTI-EBV carsid AG;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: HUMALOG. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300167782 Same reporter/patient,different drug/AE.;
Information has been received from a registered nurse concerning a 12-month female with no pertinent medical history or allergies who was vaccinated with her first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. On 03-OCT-2007 the patient developed a measle-like rash covering her whole body, a fever of 102F and a runny nose. The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested.
He has been continuously taking medication for his stomach since then.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), 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: "Blood pressure" (unspecified if ongoing); "Stress" (unspecified if ongoing); "HIV" (unspecified if ongoing); "Hyper S Protein deficiency" (unspecified if ongoing); "for his stomach" (ongoing), notes: He got his first dose. He has been continuously taking medication for his stomach since then. Concomitant medication(s) included: BIKTARVY taken for hiv infection. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "He has been continuously taking medication for his stomach since then.". Therapeutic measures were taken as a result of abdominal discomfort.  Additional information: The patient aged 65 (will be 66 in two weeks,) stated that he has Hyper S Protein deficiency, and urgently needed Paxlovid before he got the virus. He does not currently have Covid, he just has difficulty leaving the house, he can't drive and he has no family in the area to drive him to a hospital if he gets sick. He needs to have the medication at home readily available. He stated that patients with Hyper S Protein Deficiency the covid vaccine is only about 20% to mid 30s effective at best. The protein used doesn't have enough strength that he needs. He stated his condition is 1 in 20,000 but the hypo S protein deficiency rate is 1 in 500. He has been home bound since October, it is urgent that he has this stuff. He states he is under such a heavy life threatening situation. The patient is on HIV medication BIKTARVY, he is on a list of medications, all kinds, blood pressure, medications for the stress from Covid, things for his stomach, he takes it morning and evening for his stomach. He has received four doses of the Pfizer BioNTech Covid 19 vaccine. He experienced side effects from all four, He got his first dose one and half to two years ago. He has been continuously taking medication for his stomach since then. He is currently getting ready for a doctor's appointment and is getting picked up by a metavan. He has to get ready an hour and half early so he can get to his appointment on time. He also had to fight to get the HPV vaccine at his age. He was going to be in a trial for HIV.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The reporter stated that the patient was administered the first dose in GARDASIL (0.5 ml, intramuscular, lot# not provided) series on an unspecified date, second dose in November 2013 and the third dose in series on an unspecified date in January 2014. Medical assistant was called back to obtain demographic information and clarified that patient was administered the second dose (0.5 ml, intramuscular, lot# not provided) on 15-NOV-2013 and the third dose in GARDASIL series on 10-JAN-2014 (0.5 ml, intramuscular, lot# not provided). No adverse effects were reported. It was unknown if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Information has been received from a 21 year old female patient via internet. The patient had no previous known illness or behavioral issues, except for an occasional migraine headache. On 28-APR-2008 the patient was vaccinated with the first dose of GARDASIL (lot # 659180/1758U). In October 2008, IUD was removed. On 08-JAN-2009 the patient was vaccinated with the second dose of GARDASIL (lot # 661703/0651X). Concomitant therapy on 08-JAN-2009 included tetanus toxoid. The patient stated that the symptoms included: 30 lbs unexplained weight loss and hair falling out in clumps and migraines. The patient experienced sudden sharp pains all over body, which were most intense in the head, abdomen and legs. Earaches and frequent ear popping with pain and stiffness in elbows, knees, wrists and ankles and a numbness in face including lips, nose and cheeks; pressure in sinuses, stiffness and tightening in the neck. The patient had had vision problems including double vision, blurred vision, light auras, difficulty focusing and pain/pressure in and around my eyes. Frequent muscle spasms all over and a weakness/numbness/tingling in arms and pains in legs. Had experienced weak to no reflexes in the left elbow and right knee and had had chest pains and tightness. Sharp shooting pains in pelvic area/vaginal area. Also the menstrual cycle had been irregular and heaviness with pain in lower back. Cramps/Charlie horses in legs and feet and also cold hands and feet and also experiencing tremors in the legs, severe anxiety issues, causing the heart to race/blood pressure to increase, anger and irritability issues. She was unable to concentrate for any length of time. The sensation to urinate came on strong and it felt like she was going to lose control and was left with a feeling of incomplete urination. It was reported that diagnosis included: An X-ray showed her spine was straightening and CT scan showed her intestine was swollen. She had received no exact diagnosis as yet. She was to receive an MRI of her brain and neck (cervical) in August 2009 and shortly afterwards she was scheduled to see a Neurologist. The patient stated that the vaccines had completely changed her life. She had been in and out of doctors offices desperately searching for an answer. She was no longer able to perform her job the way she used to. She could not even finish a book she was just trying to enjoy. She stated that she was too tired, in too much pain, or because she was at the doctor's office. At the time of the report, the outcome was unknown. Additional information is not expected.
VARIVAX vaccine was administered 16JUL2021 following a supported temperature excursion on 28JUN2021; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions, or allergies was provided.  On 28-JUN-2021, a temperature excursion involving varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T038830 has been verified to be valid, expiration date reported and established as 17-NOV-2022) occurred. The vaccine was improperly stored at a temperature of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 16-JUL-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, administered dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported)  as prophylaxis (product storage error).
No adverse event reported.  Pt requested Moderna vaccine dose 2.  Did not present vaccine card until later on today.  Patient had Pfizer first dose vaccine instead.
Patient with history of AFIB reported a hospitalization due to entering AFIB the morning after receiving his first dose of Moderna vaccine.
Fatigue, feeling chilled/cold feet. Treatment: duloxetine. The soreness in my left arm & shoulder lasted for two months. The soreness has lessened.
There are no additional adverse events; temperature excursion/ dose of PNEUMOVAX 23 had been administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-NOV-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) once, injection, lot # T027110, expiration date: 23-MAR-2022 (exact dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 35 degrees Fahrenheit for 15 hours. Digital data logger was involved. There were no previous excursions reported. There were no additional adverse events to report. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T027110; expirationdate: 23-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Maculo papular rash c/w papular urticaria on back, abdomen and lower extremeties occuring approximately 24 hours after vaccine administration. Also noted to have loose stools.  Treatment with Benadryl 6.25 mg x 1 po then PRN for pruritis q 8 hours with close follow up and referral to Allergy for evaluation for possible egg allergy.
Vaccine given on 11/29/2021 at 2 pm. Woke up 2 hours later from a nap with vomiting, dizziness, itchy, feeling hot, flu symptoms and facial swelling. I was vomiting. Unable to keep down most food and water. I was very itchy. Hands, feet, face, back, neck, chest and buttocks (main areas) with feeling hot in those areas. Facial swelling: Eyelids swollen shut the morning of 11/20/2021 and 12/1/2021, along with nose and lip swelling. Blotchy skin: Face, upper thighs. Sores: Inside of mouth and on lips. 11/30/2021 at 6 pm, small marks/hives on lateral side of upper thigh, near buttocks. Also developed a rash between buttocks. Still having all over pain and joint swelling. Swollen lymph nodes: Armpits, elbows and behind knees. Temperature still elevated, but now under 101. Prescribed steroids, antihistamine and valacyclovir. No change with taking medications since 11/30/2021. Blood sugars: Very elevated in the 300's and 400's due to prednisone.
low temperature; headache; pain around the left arm injection site; pain/discomfort to her whole body including arms, legs, and feet; pain/discomfort to her whole body including arms, legs, and feet; generalized joint pain; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534), via an unspecified route of administration on 17Mar2021 11:30 (at the age of 77-year-old) at dose 1, single in left arm for COVID-19 immunisation. Medical history included COVID (2.5 months ago), broke her back in Jul2020, stroke in Jan1997 (takes aspirin 325 mg each day), mold allergy, grass allergy and iodine allergy. The concomitant medication included warfarin sodium (COUMADIN SODIUM). The patient previously received penicillin. It was reported that she received first Pfizer Covid vaccine dose on 17Mar2021. Since start of therapy (17Mar2021), she experienced headache, pain around the left arm injection site, and pain/discomfort to her whole body including arms, legs, and feet. Also reports generalized joint pain. She states she has had a stroke in Jan1997 and takes aspirin 325 mg each day. She reports her symptoms are improved but wants to know if she would be contagious after receiving the vaccine. The patient reports having the Covid virus and she reports her son had the Covid virus and continues to have a "rash" from the infection. She had her first shot yesterday, Pfizer Covid vaccine, states she thinks she came down with the flu now. She had the Covid about 2.5 months ago, came down with it new years day so her doctor made her wait for the vaccine since she had Covid before. She was fine when she got home yesterday, got shot at 11:30 AM, states around 7:30 PM and must have fallen asleep, when she woke up and her bones, had bad joint pain, feels much better today, has a low temperature, its down to 96.6. She broke her back in Jul2020 which is why she has gained some weight. She had a major stroke over 20 years ago, affected her right side so she got the shot in her left arm. She has a lot of allergies and is on coumadin- allergic to iodine big time, states it might kill her and also to penicillin, also to grass and mold. She has a problem with her stomach, and on medication but does not take it every day, no further information provided. All prior to vaccine. On 18Mar2021, the patient underwent lab test and procedure included body temperature: 96.6. Outcome of the events generalized joint pain and low temperature was not resolved and for other events was unknown.  No follow-up attempts are possible. No further information is expected.
no adverse event. moderna confirmed 216K22A was viable until 2/23/23 despite beyond use date of 1/22/23
Information has been received from a 55 years old female patient reporting on herself. There was no medical history or concurrent conditions. On 26-JUL-2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route and lot # were not provided). No other co-suspects were reported. No concomitant medications were reported. On 29-JUL-2012, three days later the patient's entire body was covered with raised, red and big bumps (medically significant). The patient also had low grade fever (medically significant) and she was sick to her stomach (medically significant). First, she went to a clinic, but the treatment they gave her did nothing to help, so they sent her to the ER (emergency room) on 02-AUG-2012 where she saw a physician in the ER. They gave her prednisone (manufacturer unknown), BENADRYL and a steroid shot. Blood work was performed (results were not provided). The patient's outcome was reported as recovered/resolved in August 2012. Additional information has been requested.